Every finding on record at Waterloo Visiting Nurse Association

A Recertification Survey was conducted by the Department of Inspections, Appeals and Licensing from 12/4/23 through 12/7/23 and the home health agency was found to be compliant with the Establishment of Emergency Preparedness.

A Recertification Survey was conducted by the Department of Inspections, Appeals and Licensing from 12/4/23 through 12/70/23. The survey found the agency was operating out of compliance with the following Conditions of Participation: 1) Condition of Participation 42 CFR 484.55 Comprehensive assessment of patients (G510, G514, G520, G528, G536, G546 and G548); 2) Condition of Participation 42 CFR 484.60 Care Planning, Coordination and Quality of Care (G570, G572, G576 and G580); 3) Condition of Participation 42 CFR 484.70 Infection prevention and control (G680 and G682); and 4) Condition of Participation 42 CFR 484.100 Compliance with Federal, State, and local laws (G848). The survey also found the agency operating out of compliance with other standard level regulatory requirements. As a result of the agency's noncompliance with the Medicare Conditions of Participation for home health agencies, the home health agency and its registered nurses are prohibited from providing basic skills competency training, and prohibited from providing evaluation of home health aide written basic skills testing and evaluation of demonstrated competency of the hands on basic skills for the agency's home health aides for 2 years, beginning on 12/7/23 and ending on 12/7/25. The agency reported a census of 88 patients at the time of the survey.

Comprehensive Assessment of Patients CFR(s): 484.55 Condition of participation: Comprehensive assessment of patients. Each patient must receive, and an HHA must provide, a patient-specific, comprehensive assessment. For Medicare beneficiaries, the HHA must verify the patient's eligibility for the Medicare home health benefit including homebound status, both at the time of the initial assessment visit and at the time of the comprehensive assessment. This CONDITION is not met as evidenced by: Based on agency policy review, clinical record review, patient/caregiver interview and agency staff interview, the agency failed to do the following: 1) ensure initial assessments are completed within 48 hours of referral, return home or on physician ordered start of care (G514); 2) ensure comprehensive assessments were updated timely by direct assessment in the patient's home (G520); 3) ensure comprehensive assessments included the patient's current health, psychosocial, functional, and cognitive status (G528); 4) ensure drug regimen review is included in comprehensive assessments (G536); 5) ensure comprehensive assessments were updated and revised the last five days of every 60 day period beginning with start of care by assessing the patient directly in the patient's home (G546); and 6) ensure comprehensive assessments were updated and revised 2 days after receiving knowledge of the patient's return home from an inpatient stay by assessing the patient directly in the patient's home (G548). The systemic practice resulted in the failure to ensure the organizational framework of the agency promoted and protected the rights of the agency's 88 patients.

RN performs assessment CFR(s): 484.55(a)(1) A registered nurse must conduct an initial assessment visit to determine the immediate care and support needs of the patient; and, for Medicare patients, to determine eligibility for the Medicare home health benefit, including homebound status. The initial assessment visit must be held either within 48 hours of referral, or within 48 hours of the patient's return home, or on the physician or allowed practitioner - ordered start of care date. This ELEMENT is not met as evidenced by: Based on clinical record review, policy review and agency staff interview, the agency failed to provide an initial assessment visit within 48 hours of receipt of referral, within 48 hours of the of the agency's knowledge of the patient's return home from an inpatient facility or on the physician ordered start of care date for 1 of 7 sampled patients (Patient #4). Failure to provide an initial assessment visit within 48 hours put agency patients at risk for not having immediate care needs met. Patient #4 had a start of care date of 9/8/23. Clinical record review revealed: a. Referral form which identified the referral date as 9/1/23 and a requested start of care date of 9/8/23. b. Start of Care comprehensive assessment, dated 9/8/23, identified the date of referral as 9/1/23 and date of physician-ordered start of care was marked NA (not applicable). The start of care was completed 7 days after the agency knowledge of the referral. c. The clinical record lacked documentation the physician was notified the start of care would not be completed in the 48 hour time frame. d. During an interview on 12/7/23 at 10:40 the clinical manager stated there was some issues with the start of care date related to patient being discharged from hospice services and back on home care services, and acknowledged the start of care date was scheduled around hospice discharge and family request. The agency failed to complete the start of care assessment within 48 hours of receipt of referral. The surveyor reviewed the above findings with the Administrator and Clinical Manager. The agency provided no additional information prior to the end of the survey. Findings include: According to the agency policy, titled Initial Assessment, dated 4/2018, a registered nurse will conduct an initial assessment/comprehensive assessment visit to determine the immediate care and support needs of the patient. The initial visit must be completed within 48 hours of the time of the referral and receipt of all needed documentation, the patient’s return home from an inpatient stay or the physician-ordered start of care date.

5 calendar days after start of care CFR(s): 484.55(b)(1) The comprehensive assessment must be completed in a timely manner, consistent with the patient's immediate needs, but no later than 5 calendar days after the start of care. This ELEMENT is not met as evidenced by: Based on clinical record review and agency policy review, the agency failed to ensure the comprehensive assessment was completed in a timely manner consistent with the patient’s immediate needs, but no later than 5 calendar days after the start of care for 1 of 7 sampled patients (Patient #1). Failure to complete the comprehensive assessment in a timely manner increased the potential that patients might not receive services in a manner to meet individualized patient needs. Findings include: According to the agency policy, titled Initial Assessment, dated 4/2018, the comprehensive assessment is completed in a timely manner, but no later than 5 calendar days after the start of care. According to the agency policy, titled OASIS and Comprehensive Patient Assessment, dated 4/2018, the comprehensive assessment must be completed in a timely manner, but not later than 5 calendar days after the start of care. Patient #1 had a start of care date of 11/6/23. Clinical record review revealed the initial comprehensive assessment, dated 11/6/23, electronically signed as completed on 11/12/23, 6 days after the start of care, 1 day late. The agency failed to complete the initial comprehensive assessment within 5 days of the start of care. The above findings were reviewed with the Administrator and Clinical Manager. The agency provided no additional information prior to the end of the survey.

Health, psychosocial, functional, cognition CFR(s): 484.55(c)(1) The patient's current health, psychosocial, functional, and cognitive status; This ELEMENT is not met as evidenced by: Based on clinical record review, agency procedure review and staff interview, the agency failed to ensure accurate and thorough completion of all pertinent components of each comprehensive assessment for 2 of 3 sampled patients with wounds (Patients #1 and #4). Failure to accurately and thoroughly complete comprehensive assessments to address individualized pertinent areas of health to obtain baseline findings placed patients at an increased risk of unidentified condition changes. 2.Patient #1 had a Start of Care date of 11/6/23. Clinical record review revealed the following: a. The Plan of Care, dated 11/6/23 to 1/4/23, included orders for skilled nursing services with weekly PICC (peripherally inserted central catheter) dressing change and wound monitoring. b. The start of care comprehensive assessment, dated 11/6/23, lacked documentation that the patient had a wound or PICC dressing change was completed. c. Skilled nursing visit note, dated 11/13/23, included documentation of wounds to bilateral buttocks spouse is managing, bilateral heels are boggy and wound to right heel with black open area that spouse reported was debrided by doctor recently. Note lacked documentation of wound measurements and if PICC dressing change was completed. d. Skilled nursing visit note, dated 11/21/23, included documentation the spouse managed open areas to buttock and PICC dressing change completed. The note lacked documentation regarding right heel open area and wound measurements for buttock and heel open areas or if areas were resolved. e. Skilled nursing visit note, dated 11/28/23, included documentation PICC dressing change was completed, spouse managed wounds to buttocks and heels, right heel pressure injury scabbed and measured 0.5 cm x 1 cm x 0 cm. The note lacked documentation of wound measurements for the open areas on buttocks or if areas were resolved. The nurse failed to obtain wound measurements weekly per agency expectation and complete PICC dressing change weekly per physician orders. The surveyor reviewed the above findings with the Administrator and Clinical Manager. The agency provided no additional information prior to the end of the survey. Findings include: According to the agency procedure, titled Integumentary – Pressure Ulcer and Wound Assessment, dated 9/2010, revealed wound assessment includes length, width, depth, and should be reassessed weekly. During an interview on 12/5/23 at 11:05 AM, the Administrator reported wound measurements should be documented weekly and include length, width and depth. The skilled nurse visit note includes a wound section that is completed for patients with wounds. During an interview on 12 /7/2023 at 10:40 am, the Clinical Manager reported agency expectation is for nursing staff to measure and assess wounds weekly. 1. Patient #4 had a Start of Care date of 9/8/2023. Clinical record review revealed the following: a. The Plan of Care, dated 9/8/23 to 11/6/23, included orders for skilled nursing services 3 times a week for wound care and assessment with wound measurements. b. The start of care comprehensive assessment, dated 9/8/23, included documentation that the patient had a Stage 4 pressure ulcer on the coccyx that measured 4.5 centimeters (cm) x 5.3 cm x 0.7 cm, with minimal drainage noted. c. Skilled nursing visit notes, dated 10/9/23, 10/11/23 and 10/13/23, lacked documentation of wound measurements. d. Skilled nursing visit notes, dated 10/30/23, 11/1/23 and 11/3/23, lacked documentation of wound measurements. e. The Plan of Care, dated 11/7/23 to 1/5/23, included orders for skilled nursing services 3 times a week for wound care and assessment with wound measurements obtained on Fridays and as needed (PRN). f. The recertification comprehensive assessment, dated 11/6/23, lacked documentation of wound measurements. g. Skilled nursing visit notes, dated 11/27/23 and 12/1/23, lacked documentation of wound measurements. The nurse failed to obtain wound measurements weekly per agency expectation and physician orders Findings include: According to the agency procedure, titled Integumentary – Pressure Ulcer and Wound Assessment, dated 9/2010, revealed wound assessment includes length, width, depth, and should be reassessed weekly. During an interview on 12/5/23 at 11:05 AM, the Administrator reported wound measurements should be documented weekly and include length, width and depth. The skilled nurse visit note includes a wound section that is completed for patients with wounds. During an interview on 12 /7/2023 at 10:40 am, the Clinical Manager reported agency expectation is for nursing staff to measure and assess wounds weekly. 1. Patient #4 had a Start of Care date of 9/8/2023. Clinical record review revealed the following: a. The Plan of Care, dated 9/8/23 to 11/6/23, included orders for skilled nursing services 3 times a week for wound care and assessment with wound measurements. b. The start of care comprehensive assessment, dated 9/8/23, included documentation that the patient had a Stage 4 pressure ulcer on the coccyx that measured 4.5 centimeters (cm) x 5.3 cm x 0.7 cm, with minimal drainage noted. c. Skilled nursing visit notes, dated 10/9/23, 10/11/23, 10/13/23, 10/30/23, 11/1/23 and 11/3/23, lacked documentation of wound measurements. d. The Plan of Care, dated 11/7/23 to 1/5/23, included orders for skilled nursing services 3 times a week for wound care and assessment with wound measurements obtained on Fridays and as needed (PRN). e. The recertification comprehensive assessment, dated 11/6/23, lacked documentation of wound measurements. f. Skilled nursing visit notes, dated 11/27/23 and 12/1/23, lacked documentation of wound measurements. The nurse failed to obtain wound measurements weekly per agency expectation and physician orders 2.Patient #1 had a Start of Care date of 11/6/23. Clinical record review revealed the following: a. The Plan of Care, dated 11/6/23 to 1/4/23, included orders for skilled nursing services with weekly PICC (peripherally inserted central catheter) dressing change and wound monitoring. b. The start of care comprehensive assessment, dated 11/6/23, lacked documentation that the patient had a wound or PICC dressing change was completed. c. Skilled nursing visit note, dated 11/13/23, included documentation the spouse managed open areas to buttock , bilateral heels are boggy and wound to right heel with black open area that spouse reported was debrided by doctor recently. Note lacked documentation of wound measurements and if PICC dressing change was completed. d. Skilled nursing visit note, dated 11/21/23, included documentation the spouse managed open areas to buttock and PICC dressing change completed. The note lacked documentation regarding right heel open area and wound measurements for buttock and heel open areas or if areas were resolved. e. Skilled nursing visit note, dated 11/28/23, included documentation PICC dressing change was completed, spouse managed wounds to buttocks and heels, right heel pressure injury scabbed and measured 0.5 cm x 1 cm x 0 cm. The note lacked documentation of wound measurements for the open areas on buttocks or if areas were resolved. The nurse failed to obtain wound measurements weekly per agency expectation and complete PICC dressing change weekly per physician orders. The above findings with the Administrator and Clinical Manager. The agency provided no additional information prior to the end of the survey.

A review of all current medications CFR(s): 484.55(c)(5) A review of all medications the patient is currently using in order to identify any potential adverse effects and drug reactions, including ineffective drug therapy, significant side effects, significant drug interactions, duplicate drug therapy, and noncompliance with drug therapy. This ELEMENT is not met as evidenced by: Based on agency policy review, clinical record review and agency staff interview, the agency failed to complete a drug regimen review within the required time frames as part of the initial comprehensive assessment, update to the comprehensive assessment at the time of recertification, resumption of care or discharge for 4 of 7 sampled patients (Patients #1, #2, #5 and #7). Failure to ensure medications reviewed at the time of each drug regimen review are current and accurate and failure to identify actual/ potential concerns increased the potential for unidentified medication interactions and side effect risks to the patient at the time of each comprehensive assessment. Findings Include: According to the agency policy, titled Medication Orders, dated 2/2022, medication reconciliation will take place on an on-going basis. All medication that the patient is taking as determined by the comprehensive drug review during each comprehensive assessment will be documented by the nurse. The electronic medication profile that is singed by the nurse and dated with the date of the review will be accepted as documentation. Evidence of medication reviews are to be noted in the OASIS (Outcome and Assessment Information Set) with the narrative documented that the clinician has conducted a review in order to identify any potential adverse effects and drug reactions, including ineffective drug therapy, significant side effects, significant drug interactions, duplicate drug therapy, and noncompliance with drug therapy. If there are no significant side effects, interactions, drug reactions, duplicative drug therapy and non-compliance issues, it will be documented accordingly. If issues are noted, the primary care physician is to be contacted and informed of the specific issues, and documented accordingly. According to the agency policy, titled OASIS and Comprehensive Patient Assessment, dated 4/2018, the content of the comprehensive assessment will include a review of all medications the patient is currently using in order to identify any potential adverse effects and drug reactions, including ineffective drug therapy, significant side effects, significant drug interactions, duplicate drug therapy, and noncompliance with drug therapy. During an interview on 12/6/23 at 11:45 AM with Clinical Manager, she reported the drug regimen review is completed on the case communication note – medication review. Drug interactions are identified and the note includes the medication assessment statement reviewed and documented all current patient medications per agency policy and have notified the physician of potential adverse effects, significant drug interactions, duplicate/ineffective drug therapy and potential contraindications. A printed medication list includes drug classification and is faxed to the physician with the case communication - medication review note to identify duplicate medications. The surveyor reviewed clinical records and did not identify medication lists scanned into the electronic medical record (EMR) with all case communication – medication review notes. The Clinical Manager reported the medication lists should be faxed with all case communication – medication review notes but may not always be scanned into the EMR. 1. Patient #5 had a start of care date of 5/26/23. Clinical record review revealed the following: a. Plan of Care, dated 5/26/23 to 7/24/23, included medication orders and identified duplicate medication therapy. b. The Start of Care comprehensive assessment, dated 5/26/23, lacked documentation of a drug regimen review. c. The case communication note – medication review, dated 5/29/23, lacked documentation of drug interactions, the medication assessment statement, and a copy of the medication list. The start of care drug regimen review failed to identify if medications were reviewed for noncompliance, drug interactions, ineffective therapy and side effects. d. The recertification update to the comprehensive assessment, dated 7/20/23, lacked a narrative note with a statement medication reconciliation and drug regimen review completed. e. The case communication note – medication review, dated 7/20/23, included documentation of major drug interactions, the medication assessment statement, a copy of the medication list, and a notation no changes (from previous drug regimen review). The clinical record lacked a completed drug regimen review on 5/26/23 for comparison. The recertification drug regimen review failed to identify if the patient was compliant with medications, had any significant side effects, or ineffective medication therapy. f. Plan of Care, dated 9/23/23 to 11/21/23, included medication orders for atropine-diphenoxylate, docusate (bowel medications); albuterol, Trelegy Ellipta, albuterol-ipratropium (breathing medications); midodrine, lisinopril, metoprolol (blood pressure medications); duloxetine, buspar, topiramate (depression/mood medications); multivitamin, calcium carbonate, cholecalciferol, cyanocobalamin, folic acid, magnesium oxide, ubiquinone, (supplements); and acetaminophen, camphor-menthol topical, and diclofenac topical (pain medications). g. The recertification update to the comprehensive assessment, dated 9/19/23, included documentation patient was noncompliant with taking medications, but lacked a narrative note that included the statement medication reconciliation and drug regimen review completed. h. The case communication note – medication review, dated 9/19/23, included documentation of major drug interactions and the medication assessment statement, but lacked a copy of the medication list. The drug regimen review failed to identify the duplicate bowel medications, breathing medications, blood pressure medications, depression/mood medications, supplement and pain medications, side effects and ineffective therapy. i. The resumption of care update to the comprehensive assessment, dated 10/16/23, included documentation in a narrative note, medication reconciliation and drug regimen review completed, reviewed all medications the patient is currently using in order to identify any potential adverse effects and drug reactions, including ineffective drug therapy, significant side effects, significant drug interactions, duplicate drug therapy and noncompliance with drug therapy. The note lacked documentation of the duplicate medications, interactions, compliance, side effects and ineffective therapy. The clinical record lacked a case communication note – medication review completed for the resumption of care update to the comprehensive assessment, dated 10/16/23. The drug regimen review lacked documentation of the duplicate medications, interactions, compliance, side effects and ineffective therapy. j. Plan of Care, dated 11/22/23 to 1/20/24, included medication orders for atropine-diphenoxylate, docusate (bowel medications); albuterol, Trelegy Ellipta (breathing medications); multivitamin, calcium carbonate, cholecalciferol, cyanocobalamin, folic acid, magnesium oxide, (supplements); and acetaminophen, camphor-menthol topical, and diclofenac topical (pain medications). k. The recertification update to the comprehensive assessment, dated 11/17/23, included documentation the patient was noncompliant with taking medications but lacked a narrative note that included the statement medication reconciliation and drug regimen review completed. l. The case communication note – medication review, dated 11/17/23, included documentation of major drug interaction and the medication assessment statement, but lacked a copy of the medication list. The drug regimen review failed to identify the duplicate bowel medications, breathing medications, supplement and pain medications, side effects and ineffective therapy. 2. Patient #2 had a start of care date of 7/18/22. Clinical record review revealed the following: a. Plan of Care, dated 7/18/22 to 9/15/22, included medication orders for lorazepam (antianxiety), divalproex sodium, levetiracetam (anticonvulsants), multivitamin and multivitamin with minerals (PreserVision AREDS) (supplements). b. The Start of Care comprehensive assessment, dated 7/18/22, lacked documentation of a drug regimen review. c. The case communication note – medication review, dated 7/18/22, included documentation of major drug interaction between lorazepam and divalproex and the medication assessment statement, but lacked a copy of the medication list. The drug regimen review failed to identify noncompliance and the duplicate anticonvulsant and supplement medications. d. Plans of Care, dated 9/11/23 to 11/9/23 and 11/10/23 to 1/8/24, included medication orders for lorazepam (antianxiety), divalproex sodium, levetiracetam (anticonvulsants) multivitamin, multivitamin with minerals (PreserVision AREDS) (supplements), acetaminophen, diclofenac topical, and methyl salicylate topical (pain medications). e. The recertification updates to the comprehensive assessment, dated 9/6/23 and 11/8/23, included documentation lorazepam was effective and patient compliant with taking medications. The narrative note included medication reconciliation and drug regimen review completed, reviewed all medications the patient is currently using in order to identify any potential adverse effects and drug reactions, including ineffective drug therapy, significant side effects, significant drug interactions, duplicate drug therapy and noncompliance with drug therapy. The note lacked documentation of the duplicate medications. f. The case communication notes – medication review, dated 9/6/23 and 11/8/23, included documentation of major drug interaction between lorazepam and divalproex and the medication assessment statement, but lacked a copy of the medication list. The drug regimen reviews failed to identify the duplicate anticonvulsant, supplement and pain medications. 3. Patient #7 had a start of care date of 6/24/23 and a discharge date of 8/18/23. Clinical record review revealed the following: a. The Start of Care comprehensive assessment, dated 6/24/23, included documentation in a narrative note, medication reconciliation and drug regimen review completed, reviewed all medications the patient is currently using in order to identify any potential adverse effects and drug reactions, including ineffective drug therapy, significant side effects, significant drug interactions, duplicate drug therapy and noncompliance with drug therapy. The note lacked documentation of compliance, side effects and ineffective therapy. b. The case communication note – medication review, dated 6/24/23, included documentation of major drug interaction, the medication assessment statement, and a copy of the medication list. The drug regimen review failed to identify noncompliance, side effects and ineffective therapy. c. The discharge update to the comprehensive assessment, dated 8/18/23, lacked documentation of a drug regimen review. The clinical record lacked documentation of a completed drug regimen review as part of the discharge comprehensive assessment. 4. Patient #1 had a start of care date of 11/6/23. Clinical record review revealed a Start of Care comprehensive assessment, dated 11/6/23, lacked documentation a drug regimen review had been completed. The patient's clinical record lacked a case communication – medication review note or scanned documentation of a drug regimen review. The clinical record lacked a completed drug regimen review as part of the initial comprehensive assessment. The above findings were reviewed with the Administrator and Clinical Manager. The agency provided no additional information prior to the end of the survey.

Last 5 days of every 60 days unless: CFR(s): 484.55(d)(1)(i,ii,iii) The last 5 days of every 60 days beginning with the start-of-care date, unless there is a- (i) Beneficiary elected transfer; (ii) Significant change in condition; or (iii) Discharge and return to the same HHA during the 60-day episode. This ELEMENT is not met as evidenced by: Based on clinical record review and agency policy review, the agency failed to ensure accurate completion of all required components of the recertification comprehensive assessments between day 56 and 60 of each 60 day certification period for 3 of 3 sampled patients requiring a recertification assessment (Patients #2, #4 and #5). Failure to accurately and thoroughly complete recertification comprehensive assessments in a timely manner increased the potential that patients might not receive services in a manner to meet individualized patient needs. 3. Patient # 4 had a Start of Care date of 9/8/2023. a. An update of the comprehensive assessment for recertification, dated as initiated 11/6/23, was not electronically signed as completed until 11/26/23, day 20 into the new certification period. The assessment was not completed by day 60 as required by regulation and agency policy, which was 20 days late. b. In an interview with the Clinical Manager on 12/7/2023 at 11:00 am, she stated that the recertification comprehensive assessment was missed by the nurse assigned to complete, and completed a routine note instead, so a late visit had to be completed again to get the needed information needed to complete the Recertification comprehensive assessment. The surveyor reviewed the above findings with the Administrator and Clinical Manager. The agency provided no additional information prior to the end of the survey. Findings include: According to the agency policy, titled Updating the Comprehensive Patient Assessment, dated 4/2018, the assessment must be updated no less frequently than the last 5 days of every 60 days beginning with the start of care date. 1. Patient #2 had a start of care date of 7/18/22. Clinical record review revealed: a. An update to the comprehensive assessment for recertification, dated as initiated on 7/12/23 but was not electronically signed as completed until 7/17/23, day 5 into the new certification period. The assessment was not completed by day 60 as required by regulation and agency policy, which was 5 days late. b. An update to the comprehensive assessment for recertification, dated as initiated on 11/8/23 but was not electronically signed as completed until 11/10/23, day 1 into the new certification period. The assessment was not completed by day 60 as required by regulation and agency policy, which was 1 day late. The agency failed to update the comprehensive assessment in the last 5 days of the 60 day episode. 2. Patient #5 had a start of care date of 5/26/23. Clinical record review revealed: a. An update to the comprehensive assessment for recertification, dated as initiated on 9/19/23 but was not electronically signed as completed until 9/24/23, day 2 into the new certification period. The assessment was not completed by day 60 as required by regulation and agency policy, which was 2 days late. b. An update to the comprehensive assessment for recertification, dated as initiated on 11/17/23 but was not electronically signed as completed until 11/24/23, day 3 into the new certification period. The assessment was not completed by day 60 as required by regulation and agency policy, which was 3 days late. The agency failed to update the comprehensive assessment in the last 5 days of the 60 day episode.

Within 48 hours of the patient's return CFR(s): 484.55(d)(2) Within 48 hours of the patient's return to the home from a hospital admission of 24 hours or more for any reason other than diagnostic tests, or on physician or allowed practitioner - ordered resumption date; This ELEMENT is not met as evidenced by: Based on agency policy review, clinical record review and agency staff interview, the agency failed to ensure completion of the update to the comprehensive assessment within 48 hours of the agency's knowledge of return home from an inpatient facility for 1 of 1 sampled patients requiring a resumption of care assessment (Patient #5). The agency performed 6 resumption of care assessments in the previous 6 months. Failure to complete resumption of care comprehensive assessment in a timely manner increased the potential that patients might not receive services in a manner to meet individualized patient needs. Findings include: According to the agency policy, titled Updating the Comprehensive Patient Assessment, dated 4/2018, the assessment must be updated no less frequently than within 48 hours of the patient’s return to the home from a hospital admission of 24or more hours for any reason other than diagnostic test, or on physician-ordered resumption date. Patient #5 had a start of care date of 5/26/23. Clinical record review revealed the following: a. The patient's clinical record included hospital discharge documentation, dated 10/13/23, and dated as received by the agency by facsimile on 10/13/23. The patient was referred to the agency for services, the expected date for referral to be completed was blank b. Update to the comprehensive assessment completed at resumption of care, dated 10/16/23, was electronically signed as completed on 10/17/23, 4 days after hospital discharge, 2 days late. The agency failed to complete the update to the comprehensive assessment completed at resumption of care within 48 hours of the patient’s discharge from the hospital. The surveyor reviewed the above findings with the Administrator and Clinical Manager. The agency provided no additional information prior to the end of the survey.

Care planning, coordination, quality of care CFR(s): 484.60 Condition of participation: Care planning, coordination of services, and quality of care. Patients are accepted for treatment on the reasonable expectation that an HHA can meet the patient's medical, nursing, rehabilitative, and social needs in his or her place of residence. Each patient must receive an individualized written plan of care, including any revisions or additions. The individualized plan of care must specify the care and services necessary to meet the patient-specific needs as identified in the comprehensive assessment, including identification of the responsible discipline(s), and the measurable outcomes that the HHA anticipates will occur as a result of implementing and coordinating the plan of care. The individualized plan of care must also specify the patient and caregiver education and training. Services must be furnished in accordance with accepted standards of practice. This CONDITION is not met as evidenced by: Based on clinical record review, agency policy review and agency staff interview, the agency: 1) failed to ensure each patient received services that were established by a doctor of medicine, osteopathy or podiatry (G572); 2) failed to ensure all patient care orders, including verbal orders, must be recorded in the plan of care (G576); and 3) failed to provide medications, treatments and services only as ordered by a physician (G580). The cumulative systemic practices resulted in the failure to ensure the organizational framework of the agency promoted and supported the coordination of safe and effective delivery of care to the agency's 88 patients.

Plan of care CFR(s): 484.60(a)(1) Each patient must receive the home health services that are written in an individualized plan of care that identifies patient-specific measurable outcomes and goals, and which is established, periodically reviewed, and signed by a doctor of medicine, osteopathy, or podiatry acting within the scope of his or her state license, certification, or registration. If a physician or allowed practitioner refers a patient under a plan of care that cannot be completed until after an evaluation visit, the physician or allowed practitioner is consulted to approve additions or modifications to the original plan. This STANDARD is not met as evidenced by: Based on agency policy review, clinical record review and agency staff interview, the agency failed to follow a Plan of Care established and periodically reviewed by a physician or notify the physician of the need to vary frequency of visits or inability to perform treatments/services as originally ordered on the Plan for Care for 5 of 7 sampled patients (Patients #2, #3, #4, #5 and #7). Failure to follow a Plan of Care established by a physician placed patients at risk of not receiving safe, individualized and consistent care designed to meet each patient's health care needs. 4. Patient #3 had a Start of Care Date of 11-10-2023. Clinical record review and associated agency staff interviews revealed the following: a. The Plan of Care, dated 11/10/23 to 1/8/24, included orders for Physical Therapy 1 time a week for 1 week effective 11/12/2023 - to eval and treat up to 10 visits authorized by VA (Veterans Association) and Occupational Therapy 1 time a week for 1 week effective11/12/23, to evaluate and treat up to 10 visits authorized by the VA. b. The initial Physical Therapy Evaluation occurred 11/27/2023. The clinical record lacked documentation the physician was notified the initial Physical Therapy evaluation was completed late. c. The clinical record lacked documentation an Occupational Therapy initial evaluation visit was made as of 12/7/2023, the physician was not notified or a reason why no visit was made. d. In an interview with the Physical Therapist, Staff C, she reported “that if Occupational Therapy can’t get into the home, the Physical Therapist will be working on upper body strengthening during the Physical Therapy Visits.” The clinical record lacked documentation the physician was notified of the variance in the ordered visits frequency. 5. Patient #4 had a Start of Care date 9-8-2023. Clinical record review and associated agency staff interviews revealed the following: a. Plan of Care, dated 11/7/2023-1/5/2023, included orders for Skilled Nurse frequency of 3 times per week. b. Skilled nurse visits, dated 11/20/23 and 11/22/23, lacked documentation the physician was notified of a missed visit for the week of 11/19/23. c. Skilled nurse visits, dated 11/27/23 and 12/1/23, lacked documentation the physician was notified of a missed visit for the week of 11/26/23. The clinical record lacked documentation the physician was notified of the variance in the ordered visits frequency. The surveyor reviewed the above findings with the Administrator and Clinical Manager. The agency provided no additional information prior to the end of the survey. Findings include: According to the agency policy, titled No Response/Missed Visits, dated 4/2018, identified physicians are notified of missed visits. The clinical record is update to reflect the reason(s) for the missed visit, actions taken and whether the patient’s primary physician was notified. According to the agency policy, titled Care Planning, dated 4/2018, identified if agency staff misses visits or services as required by the plan of care, the agency must notify the responsible physician of the missed visit if there is any potential for clinical impact upon the patient. The physician will determine whether the patient visit may be skipped or additional interventions are required by the agency. 1. Patient #2 had a start of care date of 7/18/22. Clinical record review revealed the following: a. The Plan of Care, dated 9/11/23 to 11/9/23, included physician orders for skilled nursing visits 1 time every week for 9 weeks and home health aide visits 2 times every week for 9 weeks. b. Home health aide visit notes, dated 10/3/23, 10/12/23 and 10/17/23. c. Documentation of a missed home health aide visit on 10/5/23. d. The clinical record lacked documentation of a second aide visit completed for the week of 10/8/23 or notification the physician was notified of a missed visit. The clinical record lacked any documentation of physician notification for the variance in the home health aide ordered frequency on the Plan of Care. 2. Patient #5 had a start of care date of 5/26/23. Clinical record review and associated agency staff interviews revealed the following: a. The interim physician order, dated 10/24/23, for physical therapy visits 2 time a week for 4 weeks. b. Physical therapy visit notes, dated 10/27/23, 11/3/23, 11/13/23 and 11/20/23. c. The clinical record lacked documentation of a second physical therapy visit completed for the weeks of 10/29/23 and 11/12/23 or notification the physician was notified of a missed visit. d. The clinical record lacked documentation of physical therapy visits completed the week of 11/5/23 or notification the physician was notified of a missed visit. e. During an interview on 12/7/23 at 1:30 PM, the Clinical Manager, reported reviewing the clinical record and was unable to locate documentation for the missed physical therapy visits. The Clinical Manager contacted the physical therapist and was informed the missed physical therapy visits had not been documented. The clinical record lacked any documentation of physician notification for the variance in the physical therapy ordered frequency. 3. Patient #7 had a start of care date of 6/23/23 and a discharge date of 8/18/23. Clinical record review revealed the following: a. The Plan of Care, dated 6/23/23 to 8/21/23, included orders for skilled nursing services 1 time a week. b. Skilled nursing visit notes, dated 7/7/23 and 7/28/23. c. Documentation of a missed skilled nurse visit on 7/13/23. d. The clinical record lacked documentation of a skilled nursing visit completed for the week of 7/16/23 or notification the physician was notified of a missed visit. The clinical record lacked any documentation of physician notification for the variance in the skilled nurse ordered frequency on the plan of care.

All orders recorded in plan of care CFR(s): 484.60(a)(3) All patient care orders, including verbal orders, must be recorded in the plan of care. This ELEMENT is not met as evidenced by: Based on agency policy review, clinical record review, and staff interview, the agency failed to maintain a working Plan of Care for patients and update the working Plans of Care with any new verbal/interim physician orders for 5 of 6 sampled patients with new verbal/interim orders. (Patients #1, #3, #5, #6 and #7) Failure to update the Plan of Care increased the potential for medication errors in administration or inaccurate provision of care. 5. Patient #3 had a start of care date of 11/10/2023. Clinical record review revealed: a. The Plan of Care, dated 11/10/2023-1/8/2023, included physician orders for Physical Therapy b. An interim physician order, dated 11/27/2023, included documentation for physical therapy for 2 tines a week for 5 weeks,. The agency failed to ensure the Plan of Care was updated to include all patient care orders. The surveyor reviewed the above findings with the Administrator and Clinical Manager. The agency provided no additional information prior to the end of the survey. Findings include: According to agency policy, titled Plan of Care, dated 4/2018, the Registered Nurse updates the plan of care as necessary. On 12/5/23 at 11:39 AM, interview with the Clinical Manager, she reported the nurse creates the interim physician order in the electronic medical record, the order is sent to the physician for signature, when the order is returned to the agency signed, the order is scanned into the electronic medical record. 1. Patient #1 had a start of care date of 11/6/23. Clinical record review revealed: a. The Plan of Care, dated 11/6/23 to 1/4/24, included physician orders for skilled nursing services. b. An interim physician order, dated 11/14/23, included documentation for physical therapy services 1 time a week for 1 week. c. An interim physician order, dated 11/20/23, included documentation for physical therapy services to evaluate plus 1 time a week for 1 week, then 2 times a week for 4 weeks. d. An interim physician order, dated 11/24/23, included documentation for doxycycline capsule. e. An interim physician order, dated 11/28/23, included documentation for daptomycin powder for injection, starting 10/27/23 and ending 11/23/23. The agency failed to ensure the Plan of Care was updated to include all patient care orders. 2. Patient #5 had a start of care date of 5/26/23. Clinical record review revealed: a. The Plan of Care, dated 9/23/23 to 11/1/23, included physician orders for skilled nursing services. b. An interim physician order, dated 10/16/23, for skilled nursing services 1 time a week for 1 week, effective 10/22/23, and physical therapy services 1 time a month for 1 month. c. An interim physician order, dated 10/18/23, for skilled nursing services 1 time a week for 1 week, effective 10/18/23, to discontinue lisinopril and remove medication from medication box. d. An interim physician order, dated 10/24/23, for physical therapy services 2 times a week for 4 weeks. e. An interim physician order, dated 10/25/23, for rimegepant tablet daily for migraine and discontinue sumatriptan. f. An interim physician order, dated 11/20/23, for physical therapy services 1 time a week for 1 week, effective 11/20/23. The agency failed to ensure the Plan of Care was updated to include all patient care orders. 3. Patient #6 had a start of care date of 1/13/23 and a discharge date of 2/10/23. Clinical record review revealed: a. The Plan of Care, dated 1/13/23 to 3/13/23, included physician orders for skilled nursing and occupational therapy services. b. An interim physician order, dated 2/6/23, for an extra skilled nurse visit, 1 time a week, effective 2/6/23. c. An interim physician order, dated 2/6/23, for sulfamethoxazole-trimethoprim tablet. The agency failed to ensure the Plan of Care was updated to include all patient care orders. 4. Patient #7 had a start of care date of 6/23/23 and a discharge date of 8/18/23. Clinical record review revealed: a. The Plan of Care, dated 6/23/23 to 8/21/23, included physician orders for skilled nursing, physical therapy, occupational therapy and home health aide services. b. An interim physician order, dated 6/27/23, for occupational therapy services 2 times a week for 2 weeks. c. An interim physician order, dated 6/29/23, for physical therapy services 1 time a week for 1 week and 2 times a week for 3 weeks. d. An interim physician order, dated 7/28/23, for request for colestipol script and wound care. e. An interim physician order, dated 8/4/23, for skilled nursing visit 1 time a week for 1 week to monitor wounds. The agency failed to ensure the Plan of Care was updated to include all patient care orders.

Only as ordered by a physician CFR(s): 484.60(b)(1) Drugs, services, and treatments are administered only as ordered by a physician or allowed practitioner. This ELEMENT is not met as evidenced by: Based on clinical record review and agency staff interview, the agency failed to provide medications, treatments or services only as ordered by the physician for 1 of 3 sampled patients with wounds (Patient #7). Failure to ensure staff obtain physician orders for administration of medications, treatments or services provided by agency staff placed agency patients at risk for inconsistent care/treatment and possible harm. Findings include: Patient #7 had a start of care date of 6/24/23. Clinical record review revealed: a. Skilled nursing visit, dated 7/28/23, included documentation the patient had an open wound, the nurse educated the patient and family to keep skin clean/dry and apply a barrier cream such as A&D ointment to protect the open areas. b. Interim physician order, dated 7/28/23, included documentation the patient had 2 open areas on buttocks and patient would like recommendations on what to do for protection. The nurse educated the patient and family to keep skin clean/dry and apply a barrier cream such as A&D ointment to protect the open areas. The nurse requested the physician to indicate what treatment they would like for these open areas. The nurse educated the patient and family on wound care without having a physician order. The surveyor reviewed the above findings with the Administrator and Clinical Manager. The agency provided no additional information prior to the end of the survey.

Infection prevention and control CFR(s): 484.70 Condition of Participation: Infection prevention and control. The HHA must maintain and document an infection control program which has as its goal the prevention and control of infections and communicable diseases. This CONDITION is not met as evidenced by: Based on agency policy review and home observation visit, the agency failed to do the following: 1) ensure agency staff follow infection prevention and control policies(G682). The systemic practice resulted in the failure to ensure the organizational framework of the agency promoted and protected the rights of the agency’s 88 patients.

Infection Prevention CFR(s): 484.70(a) Standard: Infection Prevention. The HHA must follow accepted standards of practice, including the use of standard precautions, to prevent the transmission of infections and communicable diseases. This STANDARD is not met as evidenced by: Based on clinical record review, agency policy review and home visit observation, the agency failed to ensure staff provided care in accordance with accepted infection control practices observed during a home visit for 1 of 3 sampled patients with home visits observed. (Patient #4) Failure to follow accepted standards of practice for infection control may put the patient at risk for receiving unsafe care or care that allows the spread of infection. Findings include: According to the agency policy, titled Infection Prevention and Control Plan, dated 3/2018, the agency will follow accepted standards of practice, including the use of standard precautions, to prevent the transmission of infections. Standard precautions will be used to prevent transmission of infectious agents. Standard precautions are a set of infection control practices used to prevent transmission of diseases that can be acquired by contact with blood, body fluids, non-intact skin and mucous membranes. Appropriate use of Personal Protective Equipment (PPE) refers to specialized pieces of equipment used for protection and as a barrier against infectious materials or any potential infectious disease exposure. PPE protects the caregiver’s skin. An example of PPE includes gloves. According to the agency procedure, titled Integumentary – Pressure Ulcer and Wound Assessment, dated 9/2010, stated adherence to Standard Precautions which would include the use of gloves throughout any procedure that is directly in contact with the wound. Patient #4 had a start of care date of 9/8/23. 1.During a home observation visit on 12/6/23 at 8:30 AM, with Staff B, Registered Nurse (RN), the surveyor observed wound care for a stage 4 pressure ulcer on the coccyx Staff B, RN, appropriately placed a barrier down on the bedside table and performed hand hygiene and donned a pair of gloves. The RN then placed the clean dressings and supplies on the barrier appropriately. The patient was rolled to their right side and the RN removed the soiled dressing appropriately. The RN then removed her gloves, performed hand hygiene and donned a new pair of gloves and cleansed the wound with the wound wash solution and discarded the items appropriately, then removed her gloves and performed hand hygiene once again. However, at this point, RN failed to don gloves before applying and securing the new dressing. Staff B, RN, placed the new dressing into the wound and completed securing the wound dressing with no gloves. Staff B, RN failed to put on gloves when completing the last step of ordered wound care, applying the clean dressing into the wound bed and securing the dressing The above findings were reviewed with the Administrator and Clinical Manager. The agency provided no additional information prior to the end of the survey.

HH aide supervision elements CFR(s): 484.80(h)(4)(i-vi) Home health aide supervision must ensure that aides furnish care in a safe and effective manner, including, but not limited to, the following elements: (i) Following the patient's plan of care for completion of tasks assigned to a home health aide by the registered nurse or other appropriate skilled professional; (ii) Maintaining an open communication process with the patient, representative (if any), caregivers, and family; (iii) Demonstrating competency with assigned tasks; (iv) Complying with infection prevention and control policies and procedures; (v) Reporting changes in the patient's condition; and (vi) Honoring patient rights. This ELEMENT is not met as evidenced by: Based on clinical record review, agency policy review and staff interview, the agency failed to ensure registered nurses supervising home health aides maintained documentation of a review of all required supervisory elements including following the patient plan of care, maintaining open communication with patient/caregiver, demonstrating competency of all assigned tasks, complying with infection prevention and control policies, reporting changes in the patient condition and honoring patient rights for 2 of 2 sampled patients receiving home health aide services (Patients #2 and #4). A total of 36 patients received home health aide services and the agency employed 3 home health aides at the time of the survey. Failure to ensure the supervision of home health aides by registered nurses maintained documentation of a review of all required supervisory elements increased the risk of agency staff not meeting the patients' personal care needs. 2. Patient #4 had a start of care date of 9/8/2023. Clinical record review revealed the following: a. The Plans of Care, 9/8/23 to 11/6/23 and 11/7/23 to 1/5/23 included orders for skilled nursing and home health aide services. b. Skilled nursing visit notes dated 11/3, 11/17, and 12/1, included documentation home health aide supervision was completed and the aide followed the care plan. The notes lacked documentation the nurse assessed the aide’s ability to meet the following required supervisory elements: maintaining open communication with patient/caregiver, demonstrating competency of all assigned tasks, complying with infection prevention and control policies, reporting changes in the patient condition and honoring patient rights. c. Recertification update of the comprehensive assessment, dated 11/6/23, included documentation home health aide supervision was completed and the aide followed the care plan. The note lacked documentation the nurse assessed the aide’s ability to meet the following required supervisory elements: maintaining open communication with patient/caregiver, demonstrating competency of all assigned tasks, complying with infection prevention and control policies, reporting changes in the patient condition and honoring patient rights. The surveyor reviewed the above findings with the Administrator and Clinical Manager. The agency provided no additional information prior to the end of the survey. Findings include: The agency's policy, titled Home Health Services: Home Care Aide, dated 4/2018, identified the aide is supervised by a nurse or clinical manager. During an interview on 12/5/23 at 11:05 AM, the Administrator reported home health aide supervision is documented in the electronic medical record (EMR) and available on all skilled nursing assessments. During an interview on 12/7/23 at 11:10 AM, the Clinical Nurse Manager reported she was unaware of the required elements for home health aide supervision and thought these required elements would have been incorporated in the nursing assessments in the EMR. 1. Patient #2 had a start of care date of 7/18/22. Clinical record review revealed the following: a. The Plans of Care, 9/11/23 to 11/9/23 and 11/10/23 to 1/8/24, included orders for skilled nursing and home health aide services. b. Skilled nursing visit notes, dated 10/11/23, 10/18/23, 10/25/23, 11/1/23 and 11/15/23, included documentation home health aide supervision was completed and the aide followed the care plan. The notes lacked documentation the nurse assessed the aide’s ability to meet the following required supervisory elements: maintaining open communication with patient/caregiver, demonstrating competency of all assigned tasks, complying with infection prevention and control policies, reporting changes in the patient condition and honoring patient rights. c. Recertification update of the comprehensive assessment, dated 11/8/23, included documentation home health aide supervision was completed and the aide followed the care plan. The note lacked documentation the nurse assessed the aide’s ability to meet the following required supervisory elements: maintaining open communication with patient/caregiver, demonstrating competency of all assigned tasks, complying with infection prevention and control policies, reporting changes in the patient condition and honoring patient rights.

Compliance with Federal, State, Local Law CFR(s): 484.100 Condition of participation: Compliance with Federal, State, and local laws and regulations related to the health and safety of patients. The HHA and its staff must operate and furnish services in compliance with all applicable federal, state, and local laws and regulations related to the health and safety of patients. If state or local law provides licensing of HHAs, the HHA must be licensed. This CONDITION is not met as evidenced by: Based on review of criminal background checks, child abuse and dependent adult abuse record checks, the agency allowed 2 of 4 sampled employees hired or contracted after 12/10/2020 (the date of the last survey conducted by the Department of Inspections and Appeals) without completing the required criminal history, dependent adult abuse and child abuse background checks within 30 days prior to hire (Staff A and Staff C). The agency hired 5 new employees and contracted 12 new employees since 12/10/2020. The systemic practice resulted in the failure to ensure the organizational framework of the agency promoted and supported the adherence to state regulations and coordination of safe and effective delivery of care to the agency's 88 patients. 481 IAC (Iowa Administrative Code) rule 50.9 requires Home Health Agencies complete a criminal background history check, a dependent adult abuse background history check and a child abuse background history check on each prospective employee who will have direct patient contact. The home health agency must complete these record checks prior to the date of hire of a prospective employee. If a positive criminal history, dependent adult abuse history or child abuse history is identified, the agency must seek approval to hire from the Department of Human Services. 481 IAC rule 50.9(4) limits the validity of criminal history, dependent adult abuse history, and child abuse history record checks to a period of 30 days from the date the results of the background checks were received by the agency. Should a potential employee have a delayed hire date exceeding the allowed 30 days, the agency is required to run the background checks again to search for changes that may have occurred since the last background checks. Failure to complete the required backgrounds checks according to the State of Iowa requirements placed agency patients at risk for potential harm. Findings include: 1.Staff A, Registered Nurse (RN), had a hire date of 5/1/23. Staff A's personnel file included a criminal history check, dependent adult abuse history check and child abuse history check, completed on 5/11/23. On 12/7/23 at 1:40 PM, Staff A, provided the surveyor with another criminal history check, dependent adult abuse history check and child abuse history check, dated 3/13/23. Staff A reported this background check was provided by another agency that is in the process of purchasing this agency and was kept in the personnel file at their office. The background checks were 10 days late and 49 days prior to Staff A’s date of hire. Staff A's personnel file lacked documentation of any additional background checks for criminal history, dependent adult abuse history or child abuse history completed within 30 days of the RN's hire date. The above findings were reviewed with the Administrator and Clinical Manager. The agency provided no additional information prior to the end of the survey.

Amended 1/4/2022: The #61162-C complaint investigation, conducted by the Department of Inspections and Appeals from 12/13/2021 through 12/20/2021, resulted in substantiation of the complaint allegations and found the agency operating out of compliance with related condition level deficiencies 1: Condition of Participation 42 CFR 484.60 Care Planning, Coordination and Quality of Care ( G570, G590 and G608) and 2. Condition of Participation 42 CFR 484.80 Home Health Aide Services (G750, G798 and G800). During the complaint investigation, on 12/15/21 on 2:15 PM, surveyors identified an Immediate Jeopardy situation. The agency failed to promptly alert the physician if the patient's plan of care should be altered (CFR 484.60 Care Planning, Coordination and Quality of Care Refer to G590). The Immediate Jeopardy was abated on 12/20/2021 at 1:50 PM. The survey also found the agency was operating out of compliance with the following condition level deficiencies: 3. Condition of Participation 42 CFR 484.55 Comprehensive Assessment of Patients (G510, G528, G536 and G546). The survey also found the agency was operating out of compliance with standard level deficiencies. As a result of the agency's noncompliance with the Medicare Conditions of Participation for home health agencies, the home health agency and its registered nurses are prohibited from providing basic skills training, evaluation of home health aide written basic skills testing and evaluation of demonstrated competency of the hands on basic skills for any newly hired home health aides for a period of 2 years, beginning on 12/20/2021 and ending on 12/20/2023.

Comprehensive Assessment of Patients CFR(s): 484.55 Condition of participation: Comprehensive assessment of patients. Each patient must receive, and an HHA must provide, a patient-specific, comprehensive assessment. For Medicare beneficiaries, the HHA must verify the patient's eligibility for the Medicare home health benefit including homebound status, both at the time of the initial assessment visit and at the time of the comprehensive assessment. This CONDITION is not met as evidenced by: Based on agency policy review, clinical record review and agency staff interview, the agency failed to: 1) ensure comprehensive assessments included a complete, accurate assessment of the patient's current health, psychosocial, functional, and cognitive status (G528); 2) ensure the clinician completed a drug regimen review with each comprehensive assessment, identifying any actual or potential medication concerns (G536); and 3) ensure comprehensive assessments were updated and revised the last five days of every 60 day period beginning with start of care by assessing the patient directly in the patient's home (G546). The cumulative systemic practices resulted in the failure to ensure the organizational framework of the agency promoted and supported the coordination of safe and effective delivery of care to the agency's 137 patients.

Health, psychosocial, functional, cognition CFR(s): 484.55(c)(1) The patient's current health, psychosocial, functional, and cognitive status; This ELEMENT is not met as evidenced by: Based on clinical record review, agency policy review, patient interview and agency staff interview, the agency failed to ensure accurate and thorough completion of all pertinent components of each comprehensive assessment for 4 of 10 sampled patients (Patients #2, #3, #5 and #8). The agency reported a current patient census of 137 patients at the time of the survey. Failure to accurately and thoroughly complete comprehensive assessments to address individualized pertinent areas of health to obtain baseline findings placed patients at an increased risk of unidentified condition changes. Findings include: 4. Patient #2 had a start of care date of 9/3/2021. The Plan of Care dated 9/3/21 to 11/1/21, documented the patient had a primary diagnosis of Type 2 diabetes mellitus with a foot ulcer. Clinical record review revealed the following: a. The update to the comprehensive assessment at the time of recertification, dated 10/28/2021, lacked the following physical assessment findings or inaccurate assessment findings: The integumentary status of wounds, included an intervention for the the skilled nurse stating the caregiver will demonstrate the ability to change dressings and provide ordered wound care care by the end of the episode to the left lower extremity distal and dorsal foot using betadine swabs to paint the area, cover with sterile 4x4, an ABD (abdominal) pad), and secure with gauze wrap. A new physician's order, dated 10/22/21, included an order to start using Dakin's solution 1 time per day on the wound. The assessment lacked inclusion of the current wound treatment ordered by the physician. The update also lacked an assessment of the patient's endocrine status. The above findings were reviewed with the agency Administrator and agency Clinical Manager. Agency staff provided no further information prior to the end of the survey. According to the agency's policy, titled Plan of Care and dated 4/2018, each discipline develops a plan of care based on an assessment of the patient's needs and clinical status at the time of the initial/admission visit. According to the agency's policy, titled OASIS and Comprehensive Patient Assessment and dated 4/2018, the comprehensive patient assessment will include all required documentation that reflects the current health status of the patient to ensure current needs will be met. The comprehensive assessment will reflect the current health status of the patient, including the current health, psychosocial, functional and cognitive status and the patient's medical, nursing, rehabilitative, social and discharge planning needs. 1. Patient #3 had a start of care date of 10/10/2013. Clinical record review and agency staff interview revealed the following: a. The Plans of Care, dated 8/29/2021 to 10/27/2021 and 10/28/2021 to 12/26/2021, included physician orders for skilled nurse visits every other week to set up the patients medications, complete a general assessment and monitoring the patient's mobility and safety. The Plans included physician orders for home health aide visits twice weekly to assist with personal care. b. The update to the comprehensive assessment at the time of recertification, dated 8/25/2021, documented the patient experienced incontinency of urine with nocturia (increased urination at night); skin was pink, warm and dry with no open areas; Braden score revealed no risk for skin breakdown; patient was alert and oriented to person, place and time; cooperative behavior. The summary for the same time period documented the patient had scabbed areas on the arms and back due to itching and used an antibiotic cream prescribed by the physician to treat the scabbed areas. The Plan of Care, dated 8/29/2021 to 10/27/2021, did not include any physician orders for an antibiotic cream for the scabbed areas. The Plan included an order for Nystatin powder to the lower abdominal fold until resolved (order date 4/25/2015) and Betamethasone Diproplonate cream to the groin 4 times daily as needed (order date 1/1/2016). c. The update to the comprehensive assessment at the time of recertification, dated 10/25/2021, documented the patient experienced incontinency of urine with nocturia (increased urination at night); skin was pink, warm and dry with no open areas; Braden score revealed no risk for skin breakdown; patient was alert and oriented to person, place and time; cooperative behavior. The summary for the same time period documented the patient had scabbed areas on the arms and back due to itching and used an antibiotic cream prescribed by the physician to treat the scabbed areas. The Plan of Care, dated 10/28/2021 to 12/26/2021, did not include any physician orders for an antibiotic cream for the scabbed areas. The Plan included an order for Nystatin powder to the lower abdominal fold until resolved (order date 4/25/2015) and Betamethasone Diproplonate cream to the groin 4 times daily as needed (order date 1/1/2016). d. During agency staff interview on 12/14/2021 at 1:20 PM, Staff D, RN, reported she had worked for the agency since March 2021 and had been the RN case manager for Patient #3 since that time. The RN reported the patient refused her to assess the skin directly during skilled nurse visits and comprehensive assessment visits. The assessment documentation was done based on report from the patient only without direct observation of the patient's skin. The patient was hospitalized with multiple open areas and necrotized soft tissue on 11/5/2021. (Please refer to G590 for associated information) 2. Patient #5 had a start of care date of 11/9/2021 and was discharged from agency services on 12/8/2021. Clinical record review revealed the following: a. The Plan of Care, dated 11/9/2021 to 1/7/2022, documented the patient's diagnoses included care of multiple chronic non-pressure related ulcers on the lower legs. b. The skilled nurse visit notes, dated 11/12, 11/15, 11/17, 11/22, 11/24, 11/29 and 12/1/2021, continued to document the patient had 3 chronic non-pressure related ulcers on the left lower leg and 1 chronic non-pressure related ulcer on the right leg. c. The update to the comprehensive assessment at the time of discharge, dated 12/8/2021, lacked documentation of an assessment with wound measurements for any of the chronic non-pressure related ulcers on the patient's lower legs. d. During agency staff interview on 12/14/2021 at 2:09 PM, Staff C, Registered Nurse (RN) reported she felt that the wounds were scattered across the whole bottom of the lower extremity calf so she did not measure the wounds or the entire area at discharge. 3. Patient #8 had a start of care date of 11/22/2021, was transferred to the hospital on 11/30/2021 and remained hospitalized during the survey. Clinical record review revealed the following: a. The Plan of Care, dated 11/22/2021 to 1/20/2022, included physician orders for skilled nursing visits once weekly to assess and perform dressing changes to the patient's right heel wound. b. The initial comprehensive assessment at the time of admission, dated 11/22/2021, documented the patient had one Stage 3 pressure ulcer; 1 unstageable deep tissue injury and one Stage 2 pressure ulcer. The assessment included an assessment with measurements for only one Stage 2 pressure ulcer on the patient's right heel. The assessment included only a measurement of the length and width of the wound but lacked a depth of the wound or description of the wound depth. The wound was draining a minimal amount of serosanguinous fluid so was open. c. During agency staff interview on 12/14/2021 at 3:54 PM, Staff C, RN, verified she completed the initial assessment for Patient #8. The RN reported the patient had only one wound and it was located on the right heel. The wound was a Stage 2 pressure ulcer and was open/draining. Staff C, RN, verified the identification in the assessment of a Stage 3 pressure ulcer and a deep tissue injury was inaccurate and should not have been documented in the initial comprehensive assessment.

A review of all current medications CFR(s): 484.55(c)(5) A review of all medications the patient is currently using in order to identify any potential adverse effects and drug reactions, including ineffective drug therapy, significant side effects, significant drug interactions, duplicate drug therapy, and noncompliance with drug therapy. This ELEMENT is not met as evidenced by: Based on agency policy review, clinical record review, review of hospital documents, and agency staff interview, the agency failed to complete a drug regimen review within the required time frames at start of care and as part of the updates to the comprehensive assessment for 7 of 10 sampled patients with comprehensive assessments (Patients #2, #3, #4, #6, #7, #8 and #10). The agency reported a current patient census of 137 patients. Failure to ensure medications reviewed at the time of each drug regimen review are current and accurate and failure to identify actual/ potential concerns increased the potential for unidentified medication interactions and side effect risks to the patient at the time of each comprehensive assessment. Findings Include: 6. Patient #3 had a start of care date of 10/10/2013. Clinical record review revealed the following: a. The Plans of Care, dated 6/30/2021 to 8/28/2021, 8/29/2021 to 10/27/2021 and 10/28/2021 to 12/26/2021, documented the patient's diagnoses included hypertension and atrial fibrillation. b. The updates to the comprehensive assessment at the time of recertification, dated 6/28/2021, 8/25/2021 and 10/25/2021, lacked inclusion of a drug regimen review. The Plans of Care, dated 6/30/2021 to 8/28/2021, 8/29/2021 to 10/27/2021 and 10/28/2021 to 12/26/2021, documented the patient took amlodipine, lisinopril and metoprolol, all medications taken to lower the blood pressure. The duplicate medications and the potential for hypotension when combined should have been identified during the recertification assessments. The Transfer to Inpatient Facility, dated 11/8/2021, documented Patient #3 was hospitalized on 11/5/2021, 11 days after the 10/25/2021 update to the comprehensive assessment at recertification. Review of the hospital documentation, dated 11/12/2021, revealed Patient #3 was hospitalized for treatment of wound infection/gangrene, sepsis and acute kidney injury with acute kidney failure. During the hospitalization, the patient was experiencing hypotension, requiring dose adjustment of the anti-hypertensives to correct the medication adverse effect. c. The Plan of Care, dated 8/29/2021 to 10/27/2021, did not include any physician orders for Myrbetriq. The physician interim order, dated 9/27/2021, added Myrbetriq 25 milligrams daily to the patient's medication regimen. The update to the comprehensive assessment at the time of recertification, dated 10/25/2021, lacked documentation of a drug regimen review. The skilled nurse visit note, dated 11/4/2021, documented the patient reported taking the Myrbetriq three times daily since prescribed as the patient did not think the medication was working. The physician prescribed frequency was daily. The RN was not aware of the patient's non-compliance with the medication as reported at the time of the update to the comprehensive assessment 10 days earlier due to the failure to complete the drug regimen review. 7. Patient #8 had a start of care date of 11/22/2021. Clinical record review revealed the following: a. The Plan of Care, dated 11/22/2021 to 1/20/2022, documented the patient's diagnoses included hypertension with hypertensive urgency. b. The initial comprehensive assessment completed at the time of admission, dated 11/22/2021, lacked inclusion of a drug regimen review. c. The Plan of Care, dated 11/22/2021 to 1/20/2022, documented the patient took Lasix and Lisinopril, both medications taken to lower the blood pressure. The duplicate medications and the potential for hypotension when combined should have been identified by the RN during the initial comprehensive assessment. The above stated findings were reviewed with the Administrator, the Clinical Manager and Staff F, Office Manager. The agency provided no additional information prior to the end of the survey. According to the agency policy, titled Medication Management/Monitoring and dated 3/2018, a review of all medications the patient is currently using in order to identify any potential adverse effects and drug reactions, including ineffective drug therapy, significant side effects, significant drug interactions, duplicate drug therapy, and noncompliance in drug therapy is the nurse's responsibility. It is also the nurse's responsibility to determine whether the patient is properly taking the medications ordered by the attending physician when self administered. Beginning on the admission visit, the nurse is to provide a comprehensive assessment of the patient's medications. Medication assessment is ongoing through out the patient's stay on home care. The nurse will document all aspects of the patient's medication management on the patient's clinical record. According to agency policy, titled Medication Orders and dated 3/2018, all medications the patient is taking as determined by the comprehensive drug review during each comprehensive assessment will be documented by the nurse. The electronic medication profile that is signed by the nurse and dated with the date of the review will be accepted as documentation. According to agency policy, titled OASIS and Comprehensive Patient Assessment and dated 4/2018, the comprehensive assessment will include a review of all medications the patient is currently using in order to identify any potential adverse effects and drug reactions, including ineffective drug therapy, significant side effects, significant drug interactions, duplicate drug therapy, and noncompliance with drug therapy. According to agency policy, titled Personal Care Only Program and dated, 8/2018, in order to best complete the comprehensive assessment, a current medication profile and History and Physical or last doctor's visit note should be requested from the referral source. Physician orders for personal care services must also be received. Recertification of the personal care patient occurs at least every 60 days. The comprehensive assessment is completed and medications are reviewed and updated. On 12/15/2021 at 3:16 PM, interview with the Administrator revealed the clinicians assess all medications at the time of the comprehensive assessment and should identify all areas assessed within the comprehensive assessment and provide specific documentation as to what issues were identified. 1. Patient #2 had a start of care date of 9/3/21. The initial Plan of Care, dated 9/3/21 to 11/1/21, included orders for several medications for the patient, including Bisacodyl, Milk of Magnesia, and Polyethylene Glycol (all medications used for bowels) and Acetaminophen and Oxycodone (both used for pain). Clinical record review revealed the following: a. The initial comprehensive assessment at the time of start of care, dated 9/3/21, included documentation that no issues were found during the drug regimen review. The assessment lacked documentation of the nurse's assessment of the patient's medications or completion of the required drug regimen review at the time of the start of care. b. The update to the comprehensive assessment at the time of transfer, dated 10/19/21, documented the patient's hospital inpatient admission on 10/18/21 for wound care. c. The update to the comprehensive assessment at the time of resumption of care, dated 10/22/21, included documentation that no issues were found during the drug regimen review. The assessment lacked documentation of the nurse's assessment of the patient's medications or completion of the required drug regimen review at the time of the start of care. d. The update to the comprehensive assessment at the time of recertification, dated 10/28/21, included documentation the drug regimen review did not indicate potential clinically significant medication issues. The assessment lacked documentation of the nurse's assessment of the patient's medications or completion of assessment of all of the components of the required drug regimen review. The patient's clinical record lacked documentation of completion of assessment of a drug regimen review, including identification of the duplicate medications ordered for the patient. 2. Patient #4 had a start of care date of 10/26/2020. The Plans of Care, dated 8/22/21 to 10/20/21 and 10/21/21 to 12/19/21, included orders for Coumadin, Lasix, Lipitor and Potassium Chloride. Clinical record review revealed the following: a. The update to the comprehensive assessment at recertification, dated 8/22/21, included documentation the drug regimen review did not indicate potential clinically significant medication issues. The assessment lacked documentation of the nurse's assessment of the patient's medications or completion of assessment of all of the components of the required drug regimen review. b. The update to the comprehensive assessment at recertification, dated 10/18/21, included documentation the drug regimen review did not indicate potential clinically significant medication issues. The assessment lacked documentation of the nurse's assessment of the patient's medications or completion of assessment of all of the components of the required drug regimen review. 3. Patient #6 had a start of care date of 12/19/2020. The Plans of Care, dated 8/6/21 to 10/4/21 and 10/5/21 to 12/3/21, included orders for several medications, including Glipizide, Januvia, and Metformin (all used to treat diabetes). Clinical record review revealed the following: a. The update to the comprehensive assessment at recertification, dated 9/30/21, included documentation the drug regimen review did not indicate potential clinically significant medication issues. The assessment lacked documentation of the nurse's assessment of the patient's medications or completion of assessment of all of the components of the required drug regimen review. b. The update to the comprehensive assessment at recertification, dated 12/4/21, included documentation the drug regimen review did not indicate potential clinically significant medication issues. The assessment lacked documentation of the nurse's assessment of the patient's medications or completion of assessment of all of the components of the required drug regimen review. The patient's clinical record lacked documentation of completion of assessment of a drug regimen review, including identification of the duplicate medications ordered for the patient. 4. Patient #7 had a start of care date of 8/14/19. The Plans of Care, dated 8/3/21 to 10/1/21, included orders for several medications, including multivitamin adults 50 plus, Vitamin C, Vitamin D, Vitamin E (all supplements). Clinical record review revealed the following: a. The update to the comprehensive assessment at recertification, dated 7/29/21, included documentation the drug regimen review did not indicate potential clinically significant medication issues and documented assessment of duplicate drug therapy and documented no duplicates of meds. The assessment lacked documentation of the nurse's assessment of the patient's medications or completion of assessment of all of the components of the required drug regimen review and lacked identification of the duplicate medications in use by the patient. b. The update to the comprehensive assessment at recertification, dated 9/28/21, included documentation the drug regimen review did not indicate potential clinically significant medication issues and documented assessment of duplicate drug therapy and documented no duplicates of meds. The assessment lacked documentation of the nurse's assessment of the patient's medications or completion of assessment of all of the components of the required drug regimen review. 5. Patient #10 had a start of care date of 11/1/21 and received home health aide services. Clinical record review revealed the following: a. The initial evaluation, dated 11/1/21, included a comprehensive assessment of the patient. The nurse documented the patient was dependent with management of medications, but lacked documentation of the nurse's assessment of the patient's medications or completion of assessment of all of the components of the required drug regimen review. During interview on 12/15/21 at 12:20 PM, the agency Clinical Manager revealed no Plan of Care and Drug Regimen Review were completed as they did not believe it was necessary for the patient since only home health aide services were ordered.

Last 5 days of every 60 days unless: CFR(s): 484.55(d)(1)(i,ii,iii) The last 5 days of every 60 days beginning with the start-of-care date, unless there is a- (i) Beneficiary elected transfer; (ii) Significant change in condition; or (iii) Discharge and return to the same HHA during the 60-day episode. This ELEMENT is not met as evidenced by: Based on clinical record review and agency policy review, the agency failed to ensure accurate completion of all required components of the recertification comprehensive assessments between day 56 and 60 of each 60 day certification period for 3 of 6 sampled patients requiring a recertification assessment (Patients #2, #4 and #9). The agency reported a census of 137 patients at the time of the survey. Failure to accurately and thoroughly complete recertification comprehensive assessments in a timely manner increased the potential that patients might not receive services in a manner to meet individualized patient needs. Findings include: 3. Patient #9 had a start of care date of 9/22/2020. Clinical record review revealed: a. The Plans of Care, dated 7/19/2021 to 9/16/2021 and 9/17/2021 to 11/15/2021, included physician orders for skilled nursing every other week and home health aide 3 times weekly. b. The update to the comprehensive assessment, dated 9/17/2021, was completed on 9/17/2021, the first day of the new certification period. c. The physician's interim order, dated 9/17/2021, notified the physician the comprehensive assessment was completed one day late due to scheduling with the patient and his private agency. d. The agency did not obtain physician approval to delay the update to the comprehensive assessment prior to the end of the day on day 60 of the certification period; therefore, making the assessment completion late. The above stated findings were reviewed with the Administrator, the Clinical Manager and Staff F, Office Manager. The agency did not provide any additional information prior to the end of the survey. According to the agency policy, titled Updating the Comprehensive Patient Assessment and dated 4/2018, a comprehensive assessment must be updated no less frequently than the last 5 days of every 60 days beginning with the start of care date, unless the patient has a beneficiary elected transfer, significant change in condition or discharge and return to the same agency during the 60 day episode. 1. Patient #2 had a start of care date of 9/3/21. Clinical record revealed an update to the comprehensive assessment for recertification, dated as initiated on 10/28/21 but was not electronically signed as completed until 11/3/21, day 2 into the new certification period. The assessment was not completed by day 60 as required by regulation and agency policy, which was 2 days late. The agency lacked completion of the update to the comprehensive assessment within the last 5 days of the 60 day episode. 2. Patient #4 had a start of care date of 10/26/2020. Clinical record revealed: a. An update to the comprehensive assessment for recertification, dated as initiated on 8/17/2 but was not electronically signed as completed until 8/23/21, day 2 into the new certification period. The assessment was not completed by day 60 as required by regulation and agency policy, which was 2 days late. b. An update to the comprehensive assessment for recertification, dated as initiated on 10/18/21 but was not electronically signed as completed until 10/27/21, day 7 into the new certification period. The assessment was not completed by day 60 as required by regulation and agency policy, which was 7 days late. The agency lacked completion of the updates to the comprehensive assessment within the last 5 days of the 60 day episode.

Care planning, coordination, quality of care CFR(s): 484.60 Condition of participation: Care planning, coordination of services, and quality of care. Patients are accepted for treatment on the reasonable expectation that an HHA can meet the patient's medical, nursing, rehabilitative, and social needs in his or her place of residence. Each patient must receive an individualized written plan of care, including any revisions or additions. The individualized plan of care must specify the care and services necessary to meet the patient-specific needs as identified in the comprehensive assessment, including identification of the responsible discipline(s), and the measurable outcomes that the HHA anticipates will occur as a result of implementing and coordinating the plan of care. The individualized plan of care must also specify the patient and caregiver education and training. Services must be furnished in accordance with accepted standards of practice. This CONDITION is not met as evidenced by: Based on agency policy review, clinical record review, review of hospital documents, interview with patient physicians and agency staff interview, the agency failed to: 1) ensure each patient received services that were established by a doctor of medicine, osteopathy, podiatry or by an allowed practitioner (clinical specialist, physician assistant or nurse practitioner) and/or notified the physician or practitioner of the inability to follow the Plan of Care as ordered (G572); 2) ensure all patient care orders, including verbal orders, were recorded in a working Plan of Care for all clinicians to follow (G576); 3) promptly alert the relevant physician(s) to any changes in the patient's condition or needs that suggest that outcomes are not being achieved and/or the Plan of Care should be altered (G590); and 4) ensure care delivery was coordinated in a way to meet the needs of the patient (G608). The cumulative systemic practices resulted in the failure to ensure the organizational framework of the agency promoted and supported the coordination of safe and effective delivery of care to the agency's 137 patients.

Plan of care CFR(s): 484.60(a)(1) Each patient must receive the home health services that are written in an individualized plan of care that identifies patient-specific measurable outcomes and goals, and which is established, periodically reviewed, and signed by a doctor of medicine, osteopathy, or podiatry acting within the scope of his or her state license, certification, or registration. If a physician or allowed practitioner refers a patient under a plan of care that cannot be completed until after an evaluation visit, the physician or allowed practitioner is consulted to approve additions or modifications to the original plan. This STANDARD is not met as evidenced by: Based on agency policy review, clinical record review and agency staff interview, the agency failed to follow a Plan of Care established and periodically reviewed by a physician or notify the physician of the need to vary frequency of visits or inability to perform treatments/services as originally ordered on the Plan for Care for 4 of 10 sampled patients (Patients #2, #7, #9 and #10). The agency reported a census of 137 patients at the time of the survey. Failure to follow a Plan of Care established by a physician placed patients at risk of not receiving safe, individualized and consistent care designed to meet each patient's health care needs. Findings include: 4. Patient #9 had a start of care date of 9/22/2020. Clinical record review revealed the following: a. The Plans of Care, dated 7/19/2021 to 9/16/2021, 9/17/2021 to 11/15/2021 and 11/16/2021 to 1/14/2022, documented the patient's diagnoses included lymphedema and chronic kidney disease. The Plans included physician orders for skilled nurse visits every other week and directed the nurse to monitor the patient's weight during the skilled nurse visits and review recorded weights taken by the patient every Monday and documented for the nurse. The Plans also directed the skilled nurse to assess the patient's lower extremities for edema (swelling) during each visit. b. The skilled nurse visit notes, dated 7/29/2021, 9/9/2021, 9/17/2021, 10/14/2021 and 11/11/2021, lacked documentation of the nurse's monitoring of the patient's weight and lacked documentation indicating the nurse reviewed the patient's recorded weights between skilled nurse visits. c. The skilled nurse visit notes, dated 8/26/2021 and 9/30/2021 lacked documentation of the nurse's assessment of the patient's edema in the lower extremities. d. The clinical record lacked documentation of any interim physician orders changing the Plans of Care. The clinical record lacked documentation notifying the physician of the inability to follow the Plan of Care as ordered. The above stated findings were reviewed with the Administrator, the Clinical Manager and Staff F, Office Manager. The agency provided no additional information prior to the end of the survey. According to the agency policy, titled Plan of Care and dated 4/2018, the registered nurse is responsible for overseeing the care planning process and updates the plan of care as necessary. Any revision to the plan of care due to a change in patient health status must be communicated to the patient/representative, caregiver, and any physician's issues orders for the agency plan of care. This communication must be documented in the patient record. According to the agency policy, titled Physician Plan of Care Orders and dated 4/2018, the agency will provide care, treatment and/or services according to a state licensed physician or licensed practitioner's orders or prescriptions in compliance with applicable laws and regulations. The plan of care must be reviewed and revised by the physician who is responsible for the home heal plan of care as frequently as the patient's condition or need require, but not less frequently than once every 60 days beginning with the start of care. Drugs, services, and treatments are administered only as ordered by a physician that establishes and periodically reviews the plan of care. According to the agency policy, titled Coordination of Care and dated 4/2018, registered nurses will ensure that physicians involved in the care and oversight of the patient is involved in all communication and planning. According to the agency policy, titled Care Planning and dated 4/2018, if agency staff misses visits or services as required by the plan of care, the agency must notify the responsible physician of the missed visit if there is any potential clinical impact upon the patient. The physician will determine whether the patient visit may be skipped or additional interventions are required by the agency. According to the agency policy, titled No Response/Missed Visits and dated 4/2018,each professional staff member is responsible for calling the patient prior to making a home visit. If after arrival to a a patient's home, there is no response to efforts to enter the home, investigation of the patient's location and safety is initiated. Physicians are notified of missed visits. According to agency policy, titled Personal Care Only Program and dated, 8/2018, in order to best complete the comprehensive assessment, a current medication profile and History and Physical or last doctor's visit note should be requested from the referral source. Physician orders for personal care services must also be received. Recertification of the personal care patient occurs at least every 60 days. The comprehensive assessment is completed and medications are reviewed and updated. 1. Patient #2 had a start of care date of 9/3/21. The Plans of Care, dated 9/3/21 to 11/1/21 and 11/2/21 to 12/31/2, included physician orders for skilled nursing visits 2 times per week for 9 weeks to assess the patient's vital signs with pulse oximeter, evaluate blood sugars at each visit, and if wounds are present to assess wounds each visit including measurement, condition of wound bed using color and tissue type, periwound area and drainage. The Plans of care, included an intervention will demonstrate ability to change dressings and provided ordered wound care by the end of episode to left lower extremity distal and dorsal foot using the betadine swabs to paint the area, cover with sterile 4x4, ABD (abdominal) pad, and secure with gauze wrap. Clinical record review revealed the following: a. The skilled nurse visit note, dated 10/12/21, lacked assessment of the patient's blood pressure as ordered by the physician. b. A physician order, dated 10/22/21, documented new orders for wound care to include Dakin's solution daily to the distal wound and dorsal wound. c. The skilled nurse visit note, dated 10/26/21, lacked assessment of the patient's wound and providing wound care as ordered by the physician. The note included the intervention the caregiver will demonstrate ability to change dressings and provide wound care by the end of the episode to left lower extremity distal and dorsal foot using betadine swabs to paint the area, cover with sterile 4x4, ABD (abdominal) pad, and secure with a gauze wrap and documented wound care was performed. The note documentation lacked documentation the current order of Dakin's solution for wound care was followed. d. The update to the comprehensive assessment for recertification, dated 10/28/21, included the intervention the caregiver will demonstrate ability to change dressings and provide wound care by the end of the episode to left lower extremity distal and dorsal foot using betadine swabs to paint the area, cover with sterile 4x4, ABD (abdominal) pad, and secure with a gauze wrap. The nurse documented in the narrative section the current treatment was Dakin's wet to dry dressing change daily. The note lacked documentation the current order of Dakin's solution for wound care was followed. e. The skilled nurse visit note dated 11/9/21, lacked documentation of assessment of the patient's blood sugars. The note included the intervention the caregiver will demonstrate ability to change dressings and provide wound care by the end of the episode to left lower extremity distal and dorsal foot using betadine swabs to paint the area, cover with sterile 4x4, ABD (abdominal) pad, and secure with a gauze wrap. The nurse documented in the narrative section the current treatment was Dakin's wet to dry dressing change daily. The note lacked documentation the current order of Dakin's solution for wound care was followed. f. A faxed physician's order, dated 11/10/21, included orders to continue Dakin's dressings as ordered to left plantar wound and new wound orders to a new open area to left fifth metatarsal to cover with Xeroform ABD and secure with wrap daily. g. The skilled nurse visit note, dated 11/10/21, documented the nurse was contacted by the caregiver due to wound bleeding through the dressing. The note included the intervention the caregiver will demonstrate ability to change dressings and provide wound care by the end of the episode to left lower extremity distal and dorsal foot using betadine swabs to paint the area, cover with sterile 4x4, ABD (abdominal) pad, and secure with a gauze wrap. The documentation lacked documentation the current order of Dakin's solution for wound care was followed. h. The skilled nurse visit note dated 11/16/21, lacked documentation of assessment of the patient's blood sugars. The note included the intervention the caregiver will demonstrate ability to change dressings and provide wound care by the end of the episode to left lower extremity distal and dorsal foot using betadine swabs to paint the area, cover with sterile 4x4, ABD (abdominal) pad, and secure with a gauze wrap. The nurse documented in the narrative section the current treatment was Dakin's wet to dry dressing change daily. The note lacked documentation the current order of Dakin's solution for wound care was followed. i. A faxed physician's order, dated 11/17/21, included orders to continue Dakin's dressings with ABD Ace wrap or Tubigrip to toes. j. The skilled nurse visit notes dated 11/18/21,11/24/21, 11/29/21 and 12/1/21 included the intervention the caregiver will demonstrate ability to change dressings and provide wound care by the end of the episode to left lower extremity distal and dorsal foot using betadine swabs to paint the area, cover with sterile 4x4, ABD (abdominal) pad, and secure with a gauze wrap. The nurse documented in the narrative section the current treatment was Dakin's wet to dry dressing change daily. The note lacked documentation the current order of Dakin's solution for wound care was followed. The clinical record lacked any documentation of physician notification for the variance in the tasks ordered on the Plan of Care. 2. Patient #7 had a start of care date of 8/14/19. The Plan of Care, dated 10/2/21 to 11/30/21, included physician orders for occupational therapy starting 11/8/21 with a frequency of 2 visits per week for two weeks and then weekly visits for two additional weeks. and nursing visits weekly for 9 weeks. a. The week of 11/14/21, lacked documentation of a skilled nursing visit. The clinical record lacked documentation of communication with the physician to discuss that inability to follow the Plan of Care. b. The week of 11/21, lacked documentation of an occupational therapy visit. The clinical record lacked documentation of communication with the physician to discuss that inability to follow the Plan of Care. The clinical record lacked any documentation of physician notification for the variance in the tasks ordered on the Plan of Care. 3. Patient #10 had a start of care date of 11/1/21. The patient was discharged from services on 10/1/21 due to loss of insurance and readmitted under grant payment on 11/1/21. During interview on 12/15/21 at 12:20 PM, the agency Clinical Manager revealed no Plan of Care and Drug Regimen Review were completed as the agency did not believe it was necessary for the patient since only home health aide services were ordered. The clinical record lacked any documentation of an individualized patient specific written plan of care that identified patient specific measurable outcomes and goals.

All orders recorded in plan of care CFR(s): 484.60(a)(3) All patient care orders, including verbal orders, must be recorded in the plan of care. This ELEMENT is not met as evidenced by: Based on clinical record review, and staff interview, the agency failed to maintain a working Plan of Care for patients and update the working Plans of Care with any new verbal/interim physician orders for 6 of 6 sampled patients with new verbal/interim orders. (Patients #2, #3, #4, #5, #6 and #7). The agency reported a total current census of 137 patients at the time of the survey. Failure to update the Plan of Care increased the potential for medication errors in administration or inaccurate provision of care. Findings include: 5. Patient #3 had a start of care date of 10/10/2013, was transferred to the hospital on 11/5/2021 and discharged from the agency on 12/10/2021 due to the agency's inability to locate the patient. Clinical record review revealed the following: a. The Plan of Care, dated 6/30/2021 to 8/28/2021, included physician orders for the medication Oxybutynin 5 milligrams twice daily. The physician interim order, dated 8/2/2021 and signed by the physician on 8/3/2021, discontinuing the Oxybutynin due to the patient's refusal to take the medication. The interim order was not placed on a working Plan of Care Update. The Oxybutynin remained on the Plan of Care as a medication taken by the patient through the end of the certification period of 8/28/2021 despite the physician order discontinuing the medication. b. The Plan of Care, dated 8/29/2021 to 10/27/2021, did not include any physician orders for Pantoprazole. The physician interim order, dated 9/13/2021, added Pantoprazole 40 milligrams daily to the patient's medication regimen. The interim order was not placed on a working Plan of Care Update. Pantoprazole was not added to the Plan of Care until the next certification period of 10/28/2021 to 12/26/2021. c. The Plan of Care, dated 8/29/2021 to 10/27/2021, did not include any physician orders for Myrbetriq. The physician interim order, dated 9/27/2021, added Myrbetriq 25 milligrams daily to the patient's medication regimen. The interim order was not placed on a working Plan of Care Update. Myrbetriq was not added to the Plan of Care until the next certification period of 10/28/2021 to 12/26/2021. 6. Patient #5 had a start of care date of 11/9/2021 and was discharged from agency services on 12/8/2021. Clinical record review revealed the following: a. The Plan of Care, dated 11/9/2021 to 1/7/2022, included physician order for skilled nursing, physical therapy and occupational therapy services. The physician approved frequency and duration for occupational therapy services was evaluate and treat- twice weekly for 2 weeks. b. The physician interim order, dated 11/26/2021, added an additional 2 weeks of occupational therapy visits- approving twice weekly for 2 more weeks. The additional occupational therapy visits were never added to a working Plan of Care Update. The patient was discharged prior to end of the planned certification period ended. The above stated findings were reviewed with the Administrator, the Clinical Manager and Staff F, Office Manager. The agency provided no additional findings prior to the end of the survey. On 12/14/21 at 8:35 AM, interview with the Clinical Manager revealed new orders are sent to the the physician. The electronic health record can be updated to reflect the new orders, but the agency staff have not been doing that. The nurses look at the orders section to determine what the most current orders are for the patient. 1. Patient #2 had a start of care date of 9/3/21. Clinical record review revealed: The Plan of Care, dated 9/3/21 to 11/1/21, included the intervention the caregiver will demonstrate ability to change dressings and provide ordered wound care by the end of the episode to left lower lower extremity distal and dorsal foot using betadine swabs to paint the area, cover with sterile 4x4, and secure with gauze tape and ordered skilled nursing visits weekly for 1 week, then twice per week for 8 weeks. a. An interim physician's order, dated 9/14/21, stated physical therapy evaluation visit was completed 9/14/21. The order included physical therapy visit frequency starting 9/14/21 1 time per week for 1 week, then 2 times per week for four weeks. b. An interim physician's order, dated 9/15/21, stated occupational therapy evaluation visit was completed 9/15/21. The order included occupational therapy visit frequency starting 9/15/21 1 times per week for 1 week, then 3 times per week for 2 weeks, and then 2 times per week for one week. c. An interim physician's order, dated 10/6/21, documented physical therapy discharge completed. d. An interim physician's order, dated 10/7/21, documented two new open areas on the patient's right lower posterior arm were identified and ordered wound care to paint with betadine, cover with mepilex dressing and cover with gauze. The order also ordered left plantar area to be painted with betadine and covered with gauze. e An interim physician's order, dated 10/8/21, documented to paint left plantar open area with betadine and cover with gauze and tape 1-2 times per day. The nurse will complete dressing change two times per week and the family/client will perform the remaining days. f. An interim physician's order, dated 10/19/21, ordered to place home health services on hold as patient transferred to the hospital. g. An interim physician's order, dated 10/22/21 to resume cares after return home from hospital. Wound care order changed to Dakin's wet to dry dressing change daily. The Plan of Care, dated 11/2/21 to 12/31/21, included physician orders for skilled nursing twice per week for 9 weeks and physical and occupational therapy to evaluate and treat the patient. h. The interim physician's order, dated 11/4/21, ordered physical therapy visit frequency of 1 time per week, then two times for 3 weeks, beginning 11/4/21. i. An interim physician's order, dated 11/4/21, stated occupational therapy evaluation visit was completed 11/4/21. The order included occupational visit frequency starting 11/4/21 0 times per week for 1 week, then 1 time per week for 4 weeks. j. An interim physician's order, dated 11/10/21, included new open area to left fifth metatarsal to be covered with xeroform daily and continue Dakin's dressings to left foot plantar wound. k. An interim physician's order, dated 11/17/21, included new open area to left fifth metatarsal to be covered with xeroform daily and continue Dakin's dressings to left foot plantar wound. l. An interim physician's order, dated 11/24/21, ordered to discharge from physical therapy with goals met. m. An interim physician's order, dated 11/26/21, ordered to increase prozac to 40 milligrams (mg) per day, discontinue doxepin, and start trazodone 25 mg at bedtime. n. An interim physician's order, dated 11/30/21 to discharge from occupational therapy services with goals met. o. An interim physician's order, dated 12/3/21, ordered to hold home health services due to patient's admission to hospital. The clinical record lacked any updates to the Plan of Care to include all patient care orders. 2. Patient #4 had a start of care date of 10/26/2020. Clinical record review revealed: The Plan of Care, dated 8/22/21 to 10/20/21, included orders for Coumadin 11 mg daily. a. An interim physician's order, dated 10/4/21, changed the patient's coumadin dosage to 9 mg daily and ordered to recheck in one week. b. An interim physician's order, dated 10/11/21, changed the patient's coumadin dosage to 8 mg on Tuesday and 9 mg all other days and ordered to recheck in one week. c. An interim physician's order, dated 10/11/21, decreased patient's coumadin dosage to 8.5 mg daily and ordered to recheck in two weeks. d. An interim physician's order, dated 10/18/21, changed the patient's coumadin dosage to 8 mg on Tuesday and 9 mg all other days and ordered to recheck in one week. The Plan of Care dated 10/21/21 to 12/19/21, included orders for Coumadin 11 mg daily. e. An interim physician's order, dated 11/1/21, ordered to continue 8.5 mg daily and recheck in two weeks. The clinical record lacked any updates to the Plan of Care to include all patient care orders. 3. Patient #6 had a start of care date of 12/9/2020. Clinical record review revealed: The Plan of Care, dated 10/5/21 to 12/3/21, included orders for skilled nursing visits weekly for 9 weeks and a primary diagnosis of type 2 diabetes mellitus with out complications. An interim physician's order, dated 10/20/21, discontinued blood glucose checks from the plan of care. The clinical record lacked any updates to the Plan of Care to include all the discontinued blood glucose check order. 4. Patient #7 had a start of care date of 8/14/19. Clinical record review revealed: The Plan of Care, dated 10/2/21 to 11/30/21, included orders for skilled nursing 0 times per week for 1 week, then 1 time per week for 9 weeks. a. An interim physician's order, dated 10/15/21, stated the occupational therapy evaluation was completed 10/15/21 for lymphedema wraps and included an occupational visit frequency of 1 time per week for 1 week, 3 times per week for 2 weeks, and 2 times per week for 1 week. b. An interim physician's order, dated 11/8/21, informed the reassessment was completed by occupational therapy and ordered an occupational therapy visit frequency of 2 times per week for two weeks and 1 time per week for 2 weeks. c. An interim physician's order, dated 11/29/21 to hold home health services as patient was admitted to hospital. The clinical record lacked any updates to the Plan of Care to include all patient care orders.

Promptly alert relevant physician of changes CFR(s): 484.60(c)(1) The HHA must promptly alert the relevant physician(s) or allowed practitioner(s) to any changes in the patient's condition or needs that suggest that outcomes are not being achieved and/or that the plan of care should be altered. This ELEMENT is not met as evidenced by: Based on agency policy review, clinical record review, review of hospital documents, physician/physician office staff interview and agency staff interview, the agency failed to report changes in patient clinical findings or changes in patient needs to the physician for 6 of 10 sampled patients (Patients #2, #3, #4, #6, #7 and #9). The agency provided services to 137 patients at the time of the survey. Failure to communicate the patient's status with the physician placed agency patients at risk for unidentified worsening of conditions, inappropriate treatments, or unmet home health care needs. Findings include: 3. Patient #2 had a start of care date of 9/3/21. Clinical record review revealed the following: a. The Plan of Care, dated 9/3/21 to 11/1/21, included the diagnosis of type 2 diabetes mellitus with foot ulcer and identified the need for skilled nursing for assessment and measurement of wounds with a visit frequency of 1 time per week for 1 week, then two times per week for 8 weeks. b. The initial comprehensive assessment at the time of start of care dated 9/3/21, documented Patient #2 had a left lower extremity distal and dorsal foot surgical wound that measured 10.3 centimeters (cm) in length, 4.1 cm in width, and 0.01 cm in depth. c. The skilled nurse visit note, dated 10/7/21, documented wound size of 4 centimeters in length, 3 cm in width and depth of 0.2 cm. d. The skilled nurse visit note, dated 10/15/21, documented wound size of 5 cm in length and 4 centimeters in depth. Interview on 12/14/21 at 10:33 AM with Staff C, Registered Nurse (RN), revealed the nurse did not report the increased wound measurements to the physician. The patient did receive a visit from the Wound/Ostomy Care Nurse on 10/19/21 and transferred the patient to the hospital to receive wound treatment. The agency lacked physician notification of changes in the wound size on 10/15/21. 4. Patient #4 had a start of care date of 10/26/2020. Clinical record review revealed the following: a. The Plans of Care, dated 8/22/21 to 10/20/22 and 10/21/21 to 12/19/21, included physician orders for skilled nurse visits weekly to assess vital signs and pulse ox. b. The skilled nurse visit note, dated10/4/21, documented the patient's heart rate was 48 beats per minute. The note lacked physician notification of the low heart rate. c. The skilled nurse visit note, dated10/11/21, documented the patient's heart rate was 50 beats per minute. The note lacked physician notification of the low heart rate. d. The skilled nurse visit note, dated11/15/21, documented the patient's heart rate was 49 beats per minute. The note lacked physician notification of the low heart rate. Interview with the agency Clinical Manager on 12/13/21 at 3:45 AM revealed reporting parameters for patient's pulse is 60 beats per minute or below if patient specific parameters are not established. On 12/14/21, the Clinical Manager provided the surveyor a copy of agency's reporting parameters. The heart rate (pulse) was to be reported if pulse was less than 60 beats per minute. The agency lacked physician notification of vitals signs assessment within parameters to be reported to the physician. 5. Patient #6 had a start of care date of 12/19/2020. Clinical record review revealed the following: a. The Plan of Care, dated 10/5/21 to 12/3/21, included the diagnosis of type 2 diabetes mellitus and identified the need for skilled nursing for assessment of all systems and vital signs. b. The skilled nurse visit note, dated 10/7/21, documented a 1 centimeter skin opening on the right inner buttock and the patient's caregiver was putting zinc oxide over the area and has an appointment with the physician on 10/11/21. The nurse documented contacting the physician's office to notify of the area and request an order for a pressure relieving cushion. The note lacked documentation the nurse notified the physician of the use of the Zinc Oxide for wound care. c. The skilled nurse visit note, dated 10/14/21, 10/20/21, and 11/9/21, documented the area on buttock was healing well and the patient's caregiver continued to use zinc oxide. The note lacked documentation the nurse notified the physician of the use of the Zinc Oxide for wound care. d. The skilled nurse visit note, dated 11/18/21, documented patient stepped on a nail and had a new open area on the left ball of foot that measured 2 cm by 1 cm. The patient went to the physician on 11/17 for assessment of the new wound. Interview with Staff C, RN on 12/14/21, revealed the nurse did not notify the physician to obtain physician's order for wound care. 6. Patient #7 had a start of care date of 8/14/19. Clinical record review revealed the following: a. The Plan of Care, dated 10/2/21 to 11/30/21, included the diagnosis of polyosteoarthritis and identified the patient was orient to person, place, and time and was alert, but forgetful. b. The update to the comprehensive assessment at the time of recertification, dated 9/28/21, documented the patient was alert and oriented to person, place and time, but was forgetful. c. The skilled nurse visit note, dated 11/23/21, documented the patient easily aroused, but was disoriented and the patient had slurred speech. The nurse woke the patient's caregiver and the caregiver refused to send the patient by ambulance and stated the caregiver called and left a message with the doctor's office. The caregiver was instructed to take the patient to the emergency room if no improvement seen. The note lacked nurse notification to the physician regarding the patient's mental status change. The above findings were reviewed with the agency Administrator and agency Clinical Manager. Agency staff provided no further information. According to the agency's policy, titled Care Planning and dated 4/2018, communication relevant to the patient's care provided by the agency occurs among staff, physician, patient and support system of the patient whenever necessary. Significant changes in patient condition and/or needs are communicated to the physician as soon as possible. If at any time the patient/representative refuses care on more than one occasion, the agency will attempt to identify the reason for refusal and, if unable to do so, they must communicate with the patient's responsible physician to discuss the options. All changes to the Plan of Care will be communicated to the patient's physician before the changes are implemented. According to the agency policy, titled Coordination of Care and dated 4/2018, the registered nurse will ensure that the physician is involved in the patient's care and oversight of the patient. The nurse will communicate with the physician as needed for planning needs. According to the agency policy, titled Nursing Services and dated 4/2018, the skilled nurse is responsible for communicating and coordinating with the physician. The nurse is responsible for reevaluating the patient and communicating changes in the patient's condition in writing as often as necessary. 1. Patient #3 had a start of care date of 10/10/2013. Clinical record review, review of hospital documents and associated physician office/agency staff interviews revealed the following: a. The Plans of Care, dated 8/29/2021 to 10/27/2021 and 10/28/2021 to 12/26/2021, included physician orders for skilled nurse visits every other week to set up the patients medications, complete a general assessment and monitoring the patient's mobility and safety. The Plans included physician orders for home health aide visits twice weekly to assist with personal care. b. The update to the comprehensive assessment at the time of recertification, dated 8/25/2021, documented the patient experienced incontinency of urine with nocturia (increased urination at night); skin was pink, warm and dry with no open areas; Braden score revealed no risk for skin breakdown; patient was alert and oriented to person, place and time; cooperative behavior; was compliant with medications and knowledgeable about long term medications; required assistance with bathing in a tub or shower; was independent with grooming, dressing, toilet transfers/hygiene and transfer; used a walker for ambulation. The RN performed supervision of the aide, indicating the aide was following the assignment, patient's needs were being met and no need for changes to the assignment. The summary for the same time period documented the patient had scabbed areas on the arms and back due to itching and used an antibiotic cream prescribed by the physician to treat the scabbed areas. The Plan of Care, dated 8/29/2021 to 10/27/2021, did not include any physician orders for an antibiotic cream for the scabbed areas. The Plan included an order for Nystatin powder to the lower abdominal fold until resolved (order date 4/25/2015) and Betamethasone Diproplonate cream to the groin 4 times daily as needed (order date 1/1/2016). c. The home health aide assignment to the aide for the months of August/September and October 2021 included direction to assist the patient with a sponge bath, shampoo, assist with dressing; wash/soak feet "as needed"; "apply Bacto-ointment to to affected areas" but did not indicate what affected areas to apply (no physician's order); apply Nystatin powder every visit under breast and abdominal folds" (order was only under abdominal folds); "apply Bethethaintrigluceatraine vaseline" (medication could not be found in surveyor research) but did not give direction on where to apply; and gave no direction to the aide to apply the Betamethasone Diproplonate as ordered to the groin. d. The home health aide visit notes, dated 8/27, 8/30, 9/3, 9/8, 9/10, 9/13, 9/17, 9/20, 9/24, 9/27, 9/29,10/4, 10/8, 10/11, 10/15, 10/18, 10/22 and 10/25/2021, documented the aide assisted the patient with a sponge bath; applied cream to the patient's shoulder scabs and applied vaseline to the patient's back, arms, legs, feet; assisted with dressing the patient. The patient refused shampoo approximately half of the visits. e. Skilled nurse visits, dated 9/13, 9/27 and10/11/2021, documented the patient was incontinent of urine without symptoms of urinary tract infection; skin was pink, warm and dry without open areas; supervision of the aide, indicated the aide was following the assignment, patient's needs were being met and no need for changes to the assignment. f. The update to the comprehensive assessment at the time of recertification, dated 10/25/2021, documented the patient experienced incontinency of urine with nocturia (increased urination at night); skin was pink, warm and dry with no open areas; Braden score revealed no risk for skin breakdown; patient was alert and oriented to person, place and time; cooperative behavior; was compliant with medications and knowledgeable about long term medications; required assistance with bathing in a tub or shower; was independent with grooming, dressing, toilet transfers/hygiene and transfer; used a walker for ambulation. The RN performed supervision of the aide, indicating the aide was following the assignment, patient's needs were being met and no need for changes to the assignment. The summary for the same time period documented the patient had scabbed areas on the arms and back due to itching and used an antibiotic cream prescribed by the physician to treat the scabbed areas. The Plan of Care, dated 10/28/2021 to 12/26/2021, did not include any physician orders for an antibiotic cream for the scabbed areas. The Plan included an order for Nystatin powder to the lower abdominal fold until resolved (order date 4/25/2015) and Betamethasone Diproplonate cream to the groin 4 times daily as needed (order date 1/1/2016). g. The home health aide assignment to the aide for the months of October and November 2021 included direction to assist the patient with a sponge bath, shampoo, assist with dressing; wash/soak feet "as needed"; "apply Bacto-ointment to to affected areas" but did not indicate what affected areas to apply (no physician's order); apply Nystatin powder every visit under breast and abdominal folds" (order was only under abdominal folds); "apply Bethethaintrigluceatraine vaseline" (medication could not be found in surveyor research) but did not give direction on where to apply; and gave no direction to the aide to apply the Betamethasone Diproplonate as ordered to the groin. h. The home health aide visit notes, dated 10/29/2021, documented the aide arrived to find the patient standing but dizzy. The documentation included, the patient reported dizziness earlier in the morning and stayed in bed the whole day before. The patient felt cold and was soaked with urine. The patient refused the aide to assist with bathing instead requested clean clothes be put on, wet bed linens be left with a clean pad placed on top of them. The aide did as requested by the patient. The patient did allow the aide to apply vaseline on the back and legs. The clinical record lacked documentation of the aide reporting the patient's change in condition to the RN. i. The next home health aide visit occurred on 11/1/2021. The home health aide visit note, dated 11/1/2021, documented "the patient not doing well. I walked in all I could smell is urine very strong. Patient didn't want to get up so I said I was leaving. Patient then got up so I could assist with shampoo. I seen patient was wet from the top to bottom. I had patient take everything off and I washed patient up and put clean clothes on patient and washed patient's hair. Patient had blisters all over the bottom area. It looks pretty bad. I did report it to supervisor and nurse." j. The case communication note, dated 11/3/2021, documented contact with the managed care organization (MCO) reporting the changes noted and requesting approval to be paid for an extra skilled nurse visit to assess. Approval was given. k. The clinical record included a physician's interim order, dated 11/5/2021, approving an as needed skilled nurse visit on 11/4/2021 (3 days after the aide noted significant changes in condition) to assess the patient's change in behavior, skin assessment and medication instruction. i. The skilled nurse visit note, dated (Thursday) 11/4/2021, documented the aide had reported urine and skin issues on Monday (11/1/2021). Upon arrival, the nurse documented an inability to smell urine. The patient was lying in bed. Did report dizziness and fatigue. Patient did report having blisters on the bottom but refused to allow the nurse to look at them. The patient requested the assessment be done the following day as the aide would be back and the patient wanted to get into the shower. The nurse noted the patient had not been wearing incontinence briefs all the time due to too much pain or dizziness to make it to the bathroom to change. The nurse noted the patient's clothes and bedding were wet with urine. The nurse did not assess the patient's skin, documented a plan to notify the physician but the clinical record lacked documentation of such notification of the patient's refusal for assessment or change in condition. The nurse added shower to the aide assignment for the following day. m. The home health aide visit, dated 11/5/2021, documented the aide returned to the patient's home. The documentation included, the patient was screaming at the aide- at first refusing to be showered. After coaxing, the patient did allow the aide to assist with undressing and showering. The aide documented changing the bed linens due to soaked with urine and patient got back into bed. n. The communication note, dated 11/5/2021, documented the aide called the RN to report the visit findings. The documenation included, the aide reported the patient and bed were wet and strong odor of urine in the home. "sores on bottom looked infected and there is pus coming out of them. The patient scratched one and it was gushing blood" Patient had continued to report dizziness. The RN documented calling the physician's office to report the aide's findings from the 11/5/2021 visit. Within a few minutes, the physician's office returned call to direct the RN to send the patient to the emergency room for evaluation. The RN was unable to get a response from the patient. The RN contacted the patient's case worker with the MCO, who was also unable to reach the patient. The agency was unsuccessful with reaching the patient's adult child who was the emergency contact. o. The patient was transported to the emergency room via ambulance accompanied by the adult child after a welfare check was issued. Documentation does not indicate who made the welfare check request and the surveyor was unable to reach the patient or the adult child for interview. p. Review of emergency room documentation, dated 11/5/2021, and subsequent hospital inpatient admission documentation, dated 11/12/2021, and interview with the hospital social worker revealed the patient arrived in the emergency department- unable to stand alone- could sit for only short periods of time. Physical exam revealed the patient had extensive open areas to the groin, upper thighs, buttocks, perineal area around the genitals. Clothing was stuck to some of the wounds, requiring removal after soaking with saline. The emergency room staff contacted the home health agency who reported the last visit was on 11/4/2021 and "the patient was fine." Pictures were taken, showing extensive necrotized tissue with multiple ulcers scattered across the above stated body areas. The patient was treated with IV Vancomycin and Rocephin and the application of Silvadene was initiated to the extensive areas of necrotized tissue and open wounds. After consultation, it was determined the patient was best treated on a surgical/burn unit. The patient was admitted inpatient same day. Documentation showed the patient was diagnosed and treated for Fournier's gangrene (necrotized soft tissue); wound infection; sepsis (infection in the blood); acute kidney failure with kidney injury; urinary tract infection and low blood pressures requiring adjustment to the anti-hypertensives taken by the patient. The patient was discharged from the hospital on 11/12/2021 and did not return to the services of the Waterloo VNA. q. During agency staff interview on 12/14/2021 at 1:00 PM, Staff E, Home Health Aide, reported she had been the primary aide assigned to Patient #3. The aide had worked for the agency for the past 5 years. The aide reported she visited Patient #3 three times weekly in the past then had a decrease to twice weekly for the past several months. The aide reported her assignment directed giving the patient a sponge bath, shampoo, assist with dressing and application of topical medications. The aide reported the patient had been refusing to perform a complete sponge bath, only allowing the aide to wash the top half of the body for "months". The aide reported the patient was incontinent of urine and wore incontinence briefs but refused to allow the aide to dress the patient's lower half of the body. Reported she did put Nystatin powder under the breast folds at times but not on a regular basis. She had been applying Vaseline out of the jar to the patient's feet, legs, arms, back and chest. Never applied any medicated cream or ointment to groin but did apply the ointment to the patient's scabs on the shoulder and back. The aide reported noting a change in the patient being soaked on 10/29/2021 but did not notify the RN or supervisor until after she returned on 11/1/2021 and saw the same situation. She reports she notified the RN (Staff D) and the supervisor (Clinical Manager) on 11/1/2021. Staff E, home health aide, reported "I started crying because they looked really bad." She also reported contacting the RN (Staff D) again on 11/5/2021, after seeing the extent of the blisters following showering. Staff E, Home Health Aide, reported talking about the patient's refusal of allowing her to wash up or dress the lower half of the body when in the team meetings in the months prior to this incident. "She was just a private person so she wouldn't allow a bath." The aide verified when she documented completion of the sponge bath, she had only completed bathing from the waist up and did not bath the lower half of the body. r. During agency staff interview on 12/14/2021 at 1:20 PM, Staff D, RN, reported she had worked for the agency since March 2021 and had been the RN case manager for Patient #3 since that time. She reports saw Patient #3 every other week and was aware that the patient had not been allowing the aide to wash the lower half of the body. The RN reported it was not unusual for the patient to refuse bathing from the aide. The RN reported the patient also refused her to assess the skin directly during skilled nurse visits and comprehensive assessment visits. The assessments were done based on report from the patient only. Staff D, RN, reported she did not get a report of skin issues from Staff E, Home Health Aide, on 11/1/2021 but did receive a text message from the Clinical Manager on to make a visit on 11/4/2021. Did make the visit, patient refused to allow the nurse to assess the buttocks area. Patient #3 did report would allow the aide to assist with a shower the following day so decided to have the aide go and relay what the aide saw and report to the RN. The RN reported she did not return the following day to assess during the aide's visit but the aide called and said the blisters were awful and all over. I then called patient's primary physician and was instructed to send the patient to the emergency room. I was unable to locate the patient to direct to the emergency room and unsuccessful in contacting the patient's adult child also. On 11/6/2021 did get notified from the hospital that the patient had been taken to the emergency room by ambulance the following day and had subsequently been admitted inpatient. Staff D, RN, was not sure who contacted the ambulance but confirmed it was not her. s. During agency staff interview on 12/14/2021 at 1:41 PM, the Clinical Manager reported she had been in the position for about one year and previously had been the RN case manager for Patient #3. The Clinical Manager reported she was contacted by Staff E, Home Health Aide on 11/1/2021, reporting changes in condition of Patient #3. The Clinical Manager reported the patient's RN Case Manager (Staff D) did not have time in her schedule to see the patient on 11/1, 11/2 or 11/3/2021 and the agency had to get prior approval from the patient's managed care organization (MCO) to add the extra visit for payment of the visit. The Clinical Manager talked with the MCO on 11/3/2021, received approval for payment for the visit; then scheduled the visit for 11/4/2021 and contacted Staff D, RN, to direct her to make the visit the following day. The Clinical Manager reported she was aware of the patient's refusal to allow the RN and the aide to assess the lower body "the patient was very stubborn and we can't force the patient to do it." t. During interview with Patient #3's physician's office on 12/14/2021 at 4:12 PM, the patient's clinical record (in the physician's office) did not include any report of the patient's refusal to allow care and assessments as directed by the physician in the Plans of Care and no report of skin issues on the patient's groin or buttocks until 11/4/2021. The patient was last seen on 9/7/2021 at which time the patient was started on Myrbetriq, a medication that helps the bladder muscles relax and fill the bladder more; thereby decreasing incontinence and frequency of urination. The visit note documented two small ulcers in the gluteal folds, which the physician prescribed Nystatin cream applied. Patient was to return in 2 months but ended up hospitalized before the planned visit date. The patient was not allowing the home health aide or the RN to care for and assess Patient #3 as ordered by the physician for months. Documentation in the RN and aide visit notes did not reflect this refusal. The aide did not effectively document report to the RN. The RN did not effectively document the refusal of which she was aware of and did not report the refusal to the physician. The change in condition was noted first by the aide on 10/29/2021, then noted the blisters on the patient's groin/buttocks on 11/1/2021. The Clinical Manager first obtained billing approval, then waited to fit into the regular office hours for scheduling of a skilled nurse assessment to follow up on the aides report. The skilled nurse visit did not occur until 3 days later, at which time the patient refused assessment of the area. The RN did not return to assess the patient on 11/5/2021, instead allowing the home health aide to look at the area and report to the nurse. The physician was not notified until 11/5/2021 of the patient's change in condition, 4 days after identification of the change. The patient required hospitalization for 7 days to receive IV antibiotics and initiation of wound care. 2. Patient #9 had a start of care date of 9/22/2020. Clinical record review revealed the following: a. The Plans of Care, dated 9/17/2021 to 11/15/2021 and 11/16/2021 to 1/14/2022, documented the patient's diagnoses included lymphedema and chronic kidney disease. The Plans included physician orders for skilled nurse visits every other week and directed the nurse to monitor the patient's weight during the skilled nurse visits and review recorded weights taken by the patient every Monday and documented for the nurse. The skilled nurse visit note, dated 10/28/2021, documented the patient weighed 218#. The skilled nurse visit note, dated 11/11/2021, lacked documentation of the patient's weight or any review of reported weights by the patient. The skilled nurse visit note, dated 11/26/2021, documented the patient weighed 185#, a 33 pound weight loss in one month. The clinical record lacked documentation of any communication with the patient's physician to report the weight loss. b. The Plans of Care, dated 7/19/2021 to 9/16/2021, 9/17/2021 to 11/15/2021 and 11/16/2021 to 1/14/2022, included physician orders for home health aide visits 3 times weekly. The assignment to the home health aide directed the aide to apply compression stockings covered by Juxtalite circulation aides (a wrap that goes around the calves to assist with return of fluid associated with lymphedema back to the heart thereby decreasing the edema and preventing open sores on the lower extremities) every visit. Home health aide visit notes, dated 9/3, 9/10, 9/22, 9/24, 9/27, 9/28,10/1, 10/4 and 10/27/2021, documented the patient refused to allow home health aide to apply the Juxtalite circulation aides. Home health aide visit notes, dated 9/8,13,2021, documented the aide did not apply the Juxtalite circulation aides to the patient's lower extremities but did not indicate the reason for omission. The clinical record lacked documentation of any communication with the physician to report the patient's refusal of the application of the circulation aides.

Coordinate care delivery CFR(s): 484.60(d)(4) Coordinate care delivery to meet the patient's needs, and involve the patient, representative (if any), and caregiver(s), as appropriate, in the coordination of care activities. This ELEMENT is not met as evidenced by: Based on agency policy review, clinical record review and agency staff interview, the agency failed to ensure agency staff coordinated the delivery of care in a way to meet patient individualized needs for 4 of 10 sampled patients (Patients #2, #5, #6 and #9). The agency reported a current census of 137 patients at the time of the survey. Failure to ensure agency staff effectively coordinated the delivery of care resulted in the patients not receiving care to meet individualized patient needs. Findings include: 3. Patient #2 had a start of care date of 6/16/2020. Clinical record review revealed the following: a. The Plan of Care (POC), dated 11/2/21 to 12/31/21, identified diagnoses of type 2 diabetes with a foot ulcer. The Plan of Care included physician orders for skilled nursing services 2 visits every week for nine weeks and physical therapy visits beginning 11/4/21 weekly for one week and then two times per week for three weeks, and occupational therapy visits beginning 11/4/21 one time per week for four weeks. b. Physical therapy visit note, dated 11/22/21, documented the patient went to podiatry on 11/19/21 and would decide on 11/29/21 whether or not to amputate the left lower extremity. c. Skilled nursing visit notes, dated 11/24/21,11/29/21, and 12/1/21 documented wound measurements and wound care to the left lower extremity distal and dorsal foot. d. An update to the comprehensive assessment at the time of transfer, dated 12/6/21, included documentation the patient transferred to an inpatient facility on 12/3/21 after a call was received from patient's caregiver stating patient was not feeling well. The physician was contacted and the patient was sent by ambulance to the hospital. e. A case communication note, dated 12/7/21, documented the nurse spoke with the hospital's case manager. The patient had surgery on 12/4/21 to remove the lower left extremity. The clinical record lacked coordination between the physical therapist and the registered nurse regarding the potential amputation of the patient's left foot. 4. Patient #6 had a start of care date of 12/19/2020. Clinical record review revealed the following: a. The Plan of Care, dated 10/5/21 to 12/3/21 , identified diagnoses of type 2 diabetes without complications. The Plan of Care included physician orders for skilled nursing services 1 visit every week for nine weeks. b. The skilled nursing visit note, dated 11/18/21, documented the patient developed a new open area on the left ball of foot from stepping on a nail. The patient went to the physician on 11/17 and an antibiotic was ordered and delivered to the home. c. The skilled nursing visit note, dated 11/24/21, documented measurements of the left foot plantar sore and stated the caregiver was applying betadine to the sore daily. The sore was healing well with no signs and symptoms of infection. d. An update to the comprehensive assessment at the time of transfer, dated 12/6/21, included documentation the patient transferred to an inpatient facility on 12/4/21 for cellulitis of the left lower leg. e. A case communication note, dated 12/7/21, documented the nurse spoke with the hospital's case manager. The patient had surgery on 12/4/21 to remove the lower left extremity. The clinical record lacked coordination between the registered nurse, caregiver, and physician regarding orders for wound care to the left plantar sore The agency failed to coordinate care delivery to meet the patient's needs, and involve the patient, representative and caregivers, in the coordination of care activities. The above stated findings were reviewed with the agency Administrator and agency Clinical Manager. The agency provided no additional information prior to the end of the survey. According to the agency policy, titled Care Planning and dated 4/2018, the coordination of patient care is a multidisciplinary, individualized and complementary among the respective disciplines involved in the patient's care. Communication relevant to the care provided by the agency occurs among staff, physician, patient and support system whenever necessary. Significant changes in the patient's condition and/or needs are communicated amongst staff and to the physician as needed. All staff have access to the Plan of Care to facilitate continuity and coordination of care. According to the agency policy, titled Plan of Care and dated 4/2018, multidisciplinary care conferences will be held at least monthly and more frequently if needed to promote coordination and continuity of care. Updates and changes will be documented as needed. According to the agency policy, titled Coordination of Care and dated 4/2018, the agency will ensure that all care and services provided are consistent with assessment data and that all physicians involved in the care and oversight of the patient are involved. All disciplines and services ordered in the Plan of Care are communicated with and are involved in the Plan of Care, including staff under arrangement. According to the agency policy, titled Home Care Aide and dated 4/2018, the home health aides must be members of the interdisciplinary team, must report changes in the patient's condition to the registered nurse and other appropriate skilled professionals and must complete appropriate records for the patient file. 1. Patient #5 had a start of care date of 11/9/2021 and was discharged from agency services on 12/8/2021. Clinical record review and associated agency staff interviews revealed the following: a. The Plan of Care, dated 11/9/2021 to 1/7/2022, included physician orders for skilled nursing visits 1-2 times weekly to monitor the healing of bilateral lower extremity wounds and dressing changes to include cleansing of the wounds with warm water/soap, pat dry, apply Xeroform in single layer to all open areas, cover with an ABD pad and Size F tubigrip double layered. Family to do dressing change 1-2 times per week. Dressing ordered by wound nurse every other day. b. The initial comprehensive assessment completed at start of care, dated 11/9/2021, documented the patient's family had completed the dressing change on 11/8/2021. The patient planned to have the dressing changed at the wound clinic on 11/10/2021. The skilled nurse changed the dressing on 11/12/2021. c. The next dressing needed changed on 11/14/2021 per the Plan of Care. The clinical record lacked documentation of coordination with the family to determine who would complete the dressing change. d. The skilled nurse visit note, dated 11/15/2021, documented the nurse changed the dressing during the home visit. The dressing change was due on 11/14/2021. If the family completed the dressing on 11/14/2021, then the nurse changed the dressing one day early. If the family did not change the dressing on 11/14/2021, then the nurse was changing the dressing one day late. e. The skilled nurse visit note, dated 11/17/2021, documented the nurse changed the dressing during the home visit. The clinical record lacked documentation of coordination with the family to determine who would complete the dressing change on 11/19/2021 and 11/21/2021. f. The skilled nurse visit note, dated 11/22/2021, documented the nurse changed the dressing during the home visit. The dressing change was due on 11/21/2021. If the family completed the dressing on 11/21/2021, then the nurse changed the dressing one day early. If the family did not change the dressing on 11/21/2021, then the nurse was changing the dressing one day late. g. The skilled nurse visit note, dated 11/24/2021, documented the nurse changed the dressing during the home visit. The clinical record lacked documentation of coordination with the family to determine who would complete the dressing change on 11/26/2021 and 11/28/2021. h. The skilled nurse visit note, dated 11/29/2021, documented the nurse changed the dressing during the home visit. The dressing change was due on 11/28/2021. If the family completed the dressing on 11/28/2021, then the nurse changed the dressing one day early. If the family did not change the dressing on 11/28/2021, then the nurse was changing the dressing one day late. i. During agency staff interview on 12/14/2021 at 1:41 PM, the Clinical Manager questioned why the Plan of Care stated every other day when she believed they had obtained permission to do the dressing change 3 times per week on Monday, Wednesday and Friday. "Originally they wanted us to go daily but I informed then we don't do weekend visits." j. The clinical record lacked documentation of any physician interim orders changing the frequency of Patient #5's dressing changes. k. During agency staff interview on 12/14/2021 at 3:00 PM, the Administrator reported the agency office is open Monday through Friday 8:00 AM to 4:30 PM but does offer on-call visits from 4:30 PM to 8:00 AM weekdays and 24 hour call on the weekends. The clinical record lacked documentation of communication between the nurse and the family members to adequately coordinate the patient's care to meet the patient's individualized needs. 2. Patient #9 had a start of care date of 9/22/2020. Clinical record review and associated agency staff interviews revealed the following: a. The Plans of Care, dated 7/19/2021 to 9/16/2021, 9/17/2021 to 11/15/2021 and 11/16/2021 to 1/14/2022, included physician orders for home health aide visits 3 times weekly. b. The assignment to the home health aide directed the aide to apply compression stockings covered by Juxtalite circulation aides (a wrap that goes around the calves to assist with return of fluid associated with lymphedema back to the heart thereby decreasing the edema and preventing open sores on the lower extremities) every visit. c. Home health aide visit notes, dated 9/3, 9/10, 9/22, 9/24, 9/27, 9/28, 10/1, 10/4 and 10/27/2021, documented the patient refused to allow home health aide to apply the Juxtalite circulation aides. Home health aide visit notes, dated 9/8,13,2021, documented the aide did not apply the Juxtalite circulation aides to the patient's lower extremities but did not indicate the reason for omission. The clinical record lacked documentation indicating the aide reported the patient's refusal to the registered nurse or the Clinical Manager. d. Skilled nurse visit notes, dated 9/9/2021, 9/17/2021, 9/30/2021, 10/14/2021 and 10/28/2021, included documentation of home health aide supervision. The supervisory notes documented the patient was following the plan as assigned and the aide assignment was reviewed with no changes needed. e. The clinical record lacked documentation of the nurse attempting to identify the reason for the patient's refusal of the application of the circulation aides. The clinical record lacked documentation of any communication between the aide and the registered nurse related to the patient's refusal of the application of the circulation aides.

Home health aide services CFR(s): 484.80 Condition of participation: Home health aide services. All home health aide services must be provided by individuals who meet the personnel requirements specified in paragraph (a) of this section. This CONDITION is not met as evidenced by: Based on clinical record review and agency staff interview, the agency failed to: 1) the registered nurse (RN) or other appropriate professional assigned tasks to the home health aides in a specific, individualized manner (G798); and 2) the home health aide provided care to agency patients only as ordered by the physician and following the assigned tasks as directed by the RN (G800). The cumulative systemic practices resulted in the failure to ensure the organizational framework of the agency promoted and supported the coordination of safe and effective delivery of care to the agency's 30 patients receiving home health aide services at the time of the survey.

Home health aide assignments and duties CFR(s): 484.80(g)(1) Standard: Home health aide assignments and duties. Home health aides are assigned to a specific patient by a registered nurse or other appropriate skilled professional, with written patient care instructions for a home health aide prepared by that registered nurse or other appropriate skilled professional (that is, physical therapist, speech-language pathologist, or occupational therapist). This STANDARD is not met as evidenced by: Based on clinical record review, the agency failed to provide individualized and specific written patient care instructions from a registered nurse (RN) to agency home health aides for 4 of 4 sampled patients receiving home health aide services (Patients #3, #7, #9 and #10). The agency reported a current census of 137 patients, including 30 who received care provided by a home health aide. Failure to ensure agency registered nurses provided patient specific written instructions directing the care provided by the agency's home health aides for each patient increased the risk agency patient's would receive inappropriate or inconsistent home health aide services. Findings include: 3. Patient #7 had a start of care date of 8/14/19. Clinical record review revealed the following: a. The Plans of Care, dated 8/3/2021 to 10/1/2021 and10/21/21 to 11/30/21, included physician orders for skilled nursing visits weekly and home health aide visits 2-3 times weekly. b. The assignment to the home health aide directed the aide to apply petroleum jelly to body skin and assess the skin and report as needed. The directions lacked defining what areas of the skin the petroleum jelly should be applied and did not provide specific directions to what skin concerns should be reported. It is beyond a home health aides scope of practice to perform assessments of the patient. 4. Patient #10 had a start of care date of 11/1/21. Clinical record review revealed the following: a. The Plans of Care, dated 8/3/2021 to 10/1/2021 and10/21/21 to 11/30/21, included physician orders for home health aide visits 2-3 times weekly. b. The assignment to the home health aide directed the aide to apply triamcinolone 0.1% cream topically daily as needed to reddened open sores on buttocks per patient request. The directions included daily as needed placing discretion to the aide as to whether or not the cream is needed. It is beyond a home health aides scope of practice to perform assessments of the patient. he above findings were reviewed with the agency Administrator and agency Clinical Manager. Agency staff provided no further information prior to the end of the survey. According to the agency policy, titled Personal Care Only Program and dated 4/2018, the RN will develop a care plan for the home health aide to follow. The assignment given to the home health aide will identify tasks to meet the individualized needs of the patient. 1. Patient #3 had a start of care date of 10/10/2013. Clinical record review and associated agency staff interview revealed the following: a. The Plans of Care, dated 8/29/2021 to 10/27/2021 and 10/28/2021 to 12/26/2021, included physician orders for skilled nurse visits every other week to set up the patients medications, complete a general assessment and monitoring the patient's mobility and safety. The Plans included physician orders for home health aide visits twice weekly to assist with personal care. b. The home health aide assignment to the aide for the months of August/September and October 2021 included direction to assist the patient with a sponge bath, shampoo, assist with dressing; wash/soak feet "as needed"; "apply Bacto-ointment to to affected areas" but did not indicate what affected areas to apply (no physician's order); apply Nystatin powder every visit under breast and abdominal folds" (order was only under abdominal folds); "apply Bethethaintrigluceatraine vaseline" (medication could not be found in surveyor research) but did not give direction on where to apply; and gave no direction to the aide to apply the Betamethasone Diproplonate as ordered to the groin. c. The home health aide assignment to the aide for the months of October and November 2021 included direction to assist the patient with a sponge bath, shampoo, assist with dressing; wash/soak feet "as needed"; "apply Bacto-ointment to to affected areas" but did not indicate what affected areas to apply (no physician's order); apply Nystatin powder every visit under breast and abdominal folds" (order was only under abdominal folds); "apply Bethethaintrigluceatraine vaseline" (medication could not be found in surveyor research) but did not give direction on where to apply; and gave no direction to the aide to apply the Betamethasone Diproplonate as ordered to the groin. d. During agency staff interview on 12/14/2021 at 1:00 PM, Staff E, Home Health Aide, reported she had been the primary aide assigned to Patient #3. The aide had worked for the agency for the past 5 years. The aide reported she visited Patient #3 three times weekly in the past then had a decrease to twice weekly for the past several months. The aide reported her assignment directed giving the patient a sponge bath, shampoo, assist with dressing and application of topical medications. The aide reported she did put Nystatin powder under the breast folds at times but not on a regular basis. She had been applying Vaseline out of the jar to the patient's feet, legs, arms, back and chest. Never applied any medicated cream or ointment to groin but did apply the bactoointment to the patient's scabs on the shoulder and back. e. During agency staff interview on 12/14/2021 at 1:17 PM, the Administrator reported the RN completes the assignment to the aide- gives the assignment to the receptionist and the receptionist (a non-medical staff member) transcribes the assignment onto the paper copy home health aide visit notes each month in handwriting. The Administrator reported she noted while reviewing documents during the survey that the transcribed directions for medical terms/medications had begun to morph into unrecognizable words due to spelling. (Please refer to G590 for associated information) 2. Patient #9 had a start of care date of 9/22/2020. Clinical record review and associated agency staff interviews revealed the following: a. The Plans of Care, dated 7/19/2021 to 9/16/2021, 9/17/2021 to 11/15/2021 and 11/16/2021 to 1/14/2022, included physician orders for home health aide visits 3 times weekly. b. The assignment to the home health aide directed the aide to assist the patient with a shower and assist the patient with a sponge bath. The directions lacked parameters the aide should use to determine when to assist with the shower and when to assist with a sponge bath. c. The assignment to the home health aide for August 2021 directed the aide to apply "juxtadite sleeves" bilaterally. The RN did not give the aide direction on which extremites to apply the sleeves- upper or lower. The assignment to the home health aide for September, October, November 2021 directed the aide to apply "juxadite sleeves" bilaterally. The RN did not give the aide direction on which extremities to apply the sleeves- upper or lower extremities. The physician's order was for "Juxtalite circulation aides (a wrap that goes around the calves to assist with return of fluid associated with lymphedema back to the heart thereby decreasing the edema and preventing open sores on the lower extremities) every visit. During agency staff interview on 12/14/2021 at 1:17 PM, the Administrator reported the RN completes the assignment to the aide- gives the assignment to the receptionist and the receptionist (a non-medical staff member) transcribes the assignment onto the paper copy home health aide visit notes each month in handwriting. The Administrator reported she noted while reviewing documents during the survey that the transcribed directions for medical terms/medications had begun to morph into unrecognizable words due to spelling. d. The aide assignments for August, September, October and November 2021 included one line that encompassed direction to the home health aide to shampoo the patient's hair/comb-brush the hair/shave the face all documented on the same line. The assignment was not clear if the aide should perform all three each visit or circle the ones performed. The aide was only able to mark completion once for all three tasks combined.

Services provided by HH aide CFR(s): 484.80(g)(2) A home health aide provides services that are: (i) Ordered by the physician or allowed practitioner; (ii) Included in the plan of care; (iii) Permitted to be performed under state law; and (iv) Consistent with the home health aide training. This ELEMENT is not met as evidenced by: Based on clinical record review and agency staff interview, the agency failed to ensure home health aides provided care to agency patients only as ordered by the physician, permitted under state law and/or as directed by the skilled professional assigning the home health aide to the patient for 4 of 4 sampled patients receiving home health aide services (Patients #3, #7, #9 and #10). The agency reported a current census of 137 patients, including 30 who received care provided by a home health aide. Failure to ensure that home health aide services are provided only as ordered by the physician, permitted under state law and/or as directed by the skilled professional assigning the home health aide to the patient and according to the home health aide care plan increased the risk that patients' personal care needs were not adequately met. Findings including: 3. Patient #7 had a start of care date of 8/14/19. Clinical record review revealed the following: a. The Plans of Care, dated 8/3/2021 to 10/1/2021 and 10/2/2021 to 11/30/2021, included physician orders for home health aide visits 2 to 3 times per week for personal cares. b. The assignment to the home health aide for September, October and November 2021 directed the aide to assist with transfers with use of a gait belt and included the task for the aide to shower the patient every visit. The use of a gait belt is assigned to the aide as an extension of nursing services. The Plans of Care, dated 8/3/2021 to 10/1/2021 and 10/2/2021 to 11/30/2021, included physician orders for home health aide services. c. The home health aide visit note, dated 10/6/2021, included documentation of the aide performing a sponge page due to patient having a difficult time walking. The note lacked documentation of contacting the nurse to obtain approval of performing the sponge bath. The home health aide did not follow the direction given by the RN when caring for Patient #7. 4. Patient #10 had a start of care date of 11/1/21. Clinical record review revealed the following: a. Physician orders for home health aide visits 2 to 3 times per week for personal cares. Interview on 12/16/21 at 9:11 AM with the agency Clinical Manager revealed the agency did not feel a Plan of Care was necessary for home care aide only patients. b. The assignment to the home health aide for November 2021 directed the aide to apply triamcinolone 0.1% cream topically daily as needed to reddened open sores to buttocks per patient request. The application of triamcinolone cream is assigned to the aide as an extension of nursing services. The physician orders, lacked physician approval for the RN to delegate the tasks of application of triamcinolone cream as an extension of nursing services. The above findings were reviewed with the agency Administrator and agency Clinical Manager. Agency staff provided no additional information prior to the end of the survey. According to the agency policy, titled Explanation of Home Care Aide and Homemaker Duties and dated 12/2017, the purpose of a home health aide is to provide personal care assistance. The home health aide performs tasks ordered by the physician for those who needs assistance with personal care. According to the agency policy, titled Home Health Services: Home Care Aide and dated 4/2018, the home health aide provides services that are physician ordered in the Plan of Care and permitted to perform by applicable state laws consistent with the home health aide's training. 1. Patient #3 had a start of care date of 10/10/2013. Clinical record review and associated agency staff interview revealed the following: a. The Plans of Care, dated 8/29/2021 to 10/27/2021 and 10/28/2021 to 12/26/2021, included physician orders for skilled nurse visits every other week to set up the patients medications, complete a general assessment and monitoring the patient's mobility and safety. The Plans included physician orders for home health aide visits twice weekly to assist with personal care. b. The update to the comprehensive assessment at the time of recertification, dated 8/25/2021, documented the patient experienced incontinency of urine with nocturia (increased urination at night); skin was pink, warm and dry with no open areas; patient was alert and oriented to person, place and time; cooperative behavior; required assistance with bathing in a tub or shower; was independent with grooming, dressing, toilet transfers/hygiene and transfer; used a walker for ambulation. The RN performed supervision of the aide, indicating the aide was following the assignment, patient's needs were being met and no need for changes to the assignment. c. The home health aide assignment to the aide for the months of August, September and October 2021 included direction to assist the patient with a sponge bath, shampoo, assist with dressing; wash/soak feet "as needed"; "apply Bacto-ointment to to affected areas" but did not indicate what affected areas to apply (no physician's order); apply Nystatin powder every visit under breast and abdominal folds" (order was only under abdominal folds); "apply Bethethaintrigluceatraine vaseline" (medication could not be found in surveyor research) but did not give direction on where to apply; and gave no direction to the aide to apply the Betamethasone Diproplonate as ordered to the groin. The application of medicated topicals was assigned as an extension of nursing services. The Plan of Care lacked approval from the physician for the home health aide to apply the medicated ointments. d. The home health aide visit notes, dated 8/27, 8/30, 9/3, 9/8, 9/10, 9/13, 9/17, 9/20, 9/24, 9/27, 9/29, 10/4, 10/8, 10/11,10/15, 10/18, 10/22 and 10/25/2021, documented the aide assisted the patient with a sponge bath; applied cream to the patient's shoulder scabs and applied vaseline to the patient's back, arms, legs, feet; assisted with dressing the patient. The patient refused shampoo approximately half of the visits. e. During agency staff interview on 12/14/2021 at 1:00 PM, Staff E, Home Health Aide, reported she had been the primary aide assigned to Patient #3. The aide had worked for the agency for the past 5 years. The aide reported she visited Patient #3 three times weekly in the past then had a decrease to twice weekly for the past several months. The aide reported her assignment directed giving the patient a sponge bath, shampoo, assist with dressing and application of topical medications. The aide reported the patient had been refusing to perform a complete sponge bath, only allowing the aide to wash the top half of the body for "months". The aide reported the patient was incontinent of urine and wore incontinence briefs but refused to allow the aide to dress the patient's lower half of the body. Reported she did put Nystatin powder under the breast folds at times but not on a regular basis. She had been applying Vaseline out of the jar to the patient's feet, legs, arms, back and chest. Never applied any medicated cream or ointment to groin but did apply the bacto-ointment to the patient's scabs on the shoulder and back. The aide verified when she documented completion of the sponge bath, she had only completed bathing from the waist up and did not bath the lower half of the body despite being assigned to complete a sponge bath of the entire body. (Please refer to G590 for associated information) 2. Patient #9 had a start of care date of 9/22/2020. Clinical record review revealed the following: a. The Plans of Care, dated 7/19/2021 to 9/16/2021, 9/17/2021 to 11/15/2021 and 11/16/2021 to 1/14/2022, included physician orders for home health aide visits 3 times weekly for personal care. b. The assignment to the home health aide for August, September, October and November 2021 directed the aide to apply compression stockings to the patient's lower legs and then apply Juxtalite circulation aides (a wrap that goes around the calves to assist with return of fluid associated with lymphedema back to the heart thereby decreasing the edema and preventing open sores on the lower extremities) over the compression stockings every visit. The application of compression stockings and the circulation aide are assigned to the aide as an extension of nursing services. The Plans of Care, dated 7/19/2021 to 9/16/2021, 9/17/2021 to 11/15/2021 and 11/16/2021 to 1/14/2022, lacked physician approval for the RN to delegate the tasks of application of compression stockings and circulation aides as an extension of nursing services. c. The home health aide visit notes, dated 9/8/2021 and 9/13/2021, lacked documentation of the aide applying the patient's circulation aides as assigned. The notes lacked documentation indicating the reason for the omission of the task. The home health aide did not follow the direction given by the RN when caring for Patient #9.

Discharge and transfer summaries CFR(s): 484.110(a)(6)(i-iii) (i) A completed discharge summary that is sent to the primary care practitioner or other health care professional who will be responsible for providing care and services to the patient after discharge from the HHA (if any) within 5 business days of the patient's discharge; or (ii) A completed transfer summary that is sent within 2 business days of a planned transfer, if the patient's care will be immediately continued in a health care facility; or (iii) A completed transfer summary that is sent within 2 business days of becoming aware of an unplanned transfer, if the patient is still receiving care in a health care facility at the time when the HHA becomes aware of the transfer. This ELEMENT is not met as evidenced by: Based on agency policy review, clinical record review and agency staff interview, the agency failed to complete and send a transfer summary to the physician caring for the patient at the inpatient facility after transfer within 2 business days of the patient's transfer for 5 of 5 sampled patients with transfers (Patients #2, #3, #6, #7, and #8). The agency reported a total of 23 transfers in the previous 3 month period. Failure to send the physician and other health care professionals a summary of the patient's care while receiving services from the agency in a timely manner may result in inadequate or inappropriate follow-up during inpatient care or after discharge. Findings include: 4. Patient #3 had a start of care date of 10/10/2013 and was transferred to the local hospital on 11/5/2021 without returning to the agency's services. Clinical record review revealed the following: a. The Plan of Care, dated 10/28/2021 to 12/26/2021, included physician orders for skilled nursing and home health aide services. b. The Transfer to Inpatient Facility, dated 11/8/2021, documented the patient was transferred to the local hospital for inpatient admission on 11/5/2021. c. The case communication note, dated 11/6/2021, documented a social worker from the local hospital contacted the agency by telephone to report Patient #3 was admitted to inpatient care. d. The transfer summary, dated 11/8/2021, was marked as sent to the physician caring for the patient by facsimile on 11/16/2021, 7 business days after the agency became knowledgeable of the transfer. 5. Patient #8 had a start of care date of 11/22/2021, was transferred to the hospital on 11/30/2021 and had not returned home at the time of the survey. Clinical record review revealed the following: a. The Plan of Care, dated 11/22/2021 to 1/20/2022, included physician orders for skilled nursing, physical therapy and occupational therapy. b. The Transfer to Inpatient Facility, dated 11/30/2021, documented the patient was transferred to the local hospital for inpatient admission due to weakness and an inability to stand. The patient's family member contacted the home health nurse on 11/29/2021, who directed the caregiver to have the patient evaluated at the local emergency room. The patient was transferred to the hospital via ambulance and was subsequently admitted to inpatient status. c. The case communication note, dated 11/30/2021, documented the patient contacted the home health agency on 11/30/2021 to report the inpatient admission. d. The patient's clinical record lacked any documentation of a transfer summary completed or sent to the physician caring for Patient #8 while hospitalized. The surveyors reviewed the above stated findings with the agency Administrator, the Clinical Manager and Staff F, Office Manager. The agency provided no additional information prior to the end of the survey. According to the agency policy, titled Patient Transfer and dated 4/2018, a completed transfer summary will be sent within two business days of a planned transfer if the patient's care will be immediately continued in a health care facility. A completed transfer summary will be went within two business days of becoming aware of an unplanned transfer, if the patient is receiving care in a healthcare facility at the time the agency becomes aware of transfer. For Medicare patients, the agency will complete a transfer to inpatient facility OASIS assessment for an inpatient stay of 24 hours or more for any reason other than diagnostic testing within 48 hours of knowledge of the occurrence. The transfer summary will contain admission and discharge dates, physician responsible for the home health plan of care, reason for admission to home health, type of services provided and frequency of services, laboratory data, medications the patient is on at the time of discharge, patient's discharge condition, patient outcomes in meeting the goals in the plan of care3, and patient and family post discharge instructions. Interview on 12/15/21 at 3:35 with agency Clinical Manager revealed the agency sends an order to the plan of care physician when a patient transfers to an inpatient facility and no other summary is sent for transfers. 1. Patient #2 had a start of care date of 9/3/21. Clinical record review revealed: a. An update to the comprehensive assessment at the time of transfer, dated 10/19/21, included documentation the patient was transferred to inpatient facility for wound care on 10/18/21. b. An update to the comprehensive assessment at the time of resumption of care, dated 10/22/21, included documentation the patient was transferred to inpatient facility for wound care on 10/18/21 and was discharged from the inpatient facility on 10/22/21. The clinical record lacked documentation of a completed transfer summary. 2. Patient #6 had a start of care date of 12/19/2020. Clinical record review revealed an update to the comprehensive assessment at the time of transfer, dated 12/6/21, included documentation the patient was transferred to inpatient facility for wound care on 12/421. The clinical record lacked documentation of a completed transfer summary. 3. Patient #7 had a start of care date of 8/14/19. Clinical record review revealed the following: a. The home care aide visit note, dated 11/26/21, documented the aide completed a sponge bath and the patient was leaning to the right side and required caregiver's help to stand and wash the patient. Patient #7 was very confused and having a difficult time finding words and patient's caregiver called the ambulance to transport to the hospital. b. An update to the comprehensive assessment at the time of transfer, dated 11/30/21, included documentation the patient was transferred to inpatient facility for wound care on 11/29/21. The assessment documented a narrative note revealing the patient was admitted to the hospital on 10/26/21 for sepsis. The clinical record lacked documentation of a completed transfer summary.